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1.  A Comparison between Sedative Effect of Propofol-Fentanyl and Propofol-Midazolam Combinations in Microlaryngeal Surgeries 
Considering the growing trend of laryngeal surgeries and the need to protect the airway during and after surgery, among several therapeutic regimens to induce sedation, two regimens of propofol-fentanyl and propofol-midazolam were compared in microlaryngeal surgeries.
Forty ASA I-II class patients undergoing microlaryngeal surgeries and referring routinely for postoperative visits were randomly recruited into two groups. For all the patients, 0.5 mg/Kg of propofol was used as bolus and then, 50 mcg/Kg/min of the drug was infused intravenously. For one group, 0.03 mg/Kg bolus of midazolam and for the other group, 2 mcg/Kg bolus of fentanyl was administered in combination with propofol. Ramsay system was used in order to evaluate the effect of the two drugs in inducing sedation. The need for additional dose, blood pressure, heart rate, arterial blood oxygen saturation, and also recovery time and adverse effects such as nausea/vomiting and recalling intra-operative memories, were assessed.
The patients in the two groups were not statistically different regarding the number of patients, age, sex, preoperative vital signs, the need for additional doses of propofol, systolic blood pressure and mean systolic blood pressure during laryngoscopy. However, mean systolic blood pressure 1 min after removal of laryngoscope returned faster to the baseline in midazolam group (p < 0.01). Mean heart rate returned sooner to the baseline in fentanyl group following removal of stimulation. Besides, heart rate showed a more reduction following administration of fentanyl (p < 0.02). Mean arterial blood oxygen saturation during laryngoscopy significantly decreased in fentanyl group (p < 0.05) compared to the other group. The time it took to achieve a full consciousness was shorter in midazolam group (p < 0.01). Nausea/vomiting was significantly more prevalent in fentanyl group while the patients in midazolam group apparently experienced more of amnesia, comparatively (p < 0.01).
Inducing laryngeal block and local anesthesia using propofol-midazolam regimen is not only associated with a more rapid recovery and less recalling of unpleasant memories, but also better in preventing reduction of arterial oxygen saturation during laryngoscopy compared with propofol-fentanyl regimen.
PMCID: PMC3813093  PMID: 24250451
Sedation; Microlaryngeal surgery; Propofol; Midazolam; Fentanyl
2.  Arousal time from sedation during spinal anaesthesia for elective infraumbilical surgeries: Comparison between propofol and midazolam 
Indian Journal of Anaesthesia  2014;58(4):403-409.
Background and Aims:
Studies have already compared propofol and midazolam as sedatives during regional anaesthesia. A few studies have focused on recovery characteristics and very few have utilised both instrumental and clinical sedation monitoring for assessing recovery time. This study was designed primarily to compare arousal time from sedation using propofol with that of midazolam during spinal anaesthesia for infraumbilical surgeries, while depth of sedation was monitored continuously with bispectral index (BIS) monitor. The correlation between the BIS score and observer's assessment of awareness/sedation (OAA/S) score during recovery from sedation was also studied.
A total of 110 patients were randomly assigned to receive either propofol (Group P, n = 55) or midazolam (Group M, n = 55). Patients in the Group P received bolus of propofol (1 mg/kg), followed by infusion at 3 mg/kg/h; Group M received bolus of midazolam (0.05 mg/kg), followed by infusion at 0.06 mg/kg/h and titration until BIS score 70 was achieved and maintained between 65 and 70. OAA/S score was noted at BIS 70 and again at BIS 90 during recovery. The time to achieve OAA/S score 5 was noted. Spearman's correlation was calculated between the arousal time from sedation and the time taken to reach an OAA/S score of 5 in both the study groups.
Arousal time from sedation was found lower for Group P compared to Group M (7.54 ± 3.70 vs. 15.54 ± 6.93 min, respectively, P = 0.000). The time taken to reach OAA/S score 5 was also found to be lower for Group P than Group M (6.81 ± 2.54 min vs. 13.51 ± 6.24 min, respectively, P = 0.000).
A shorter arousal time from sedation during spinal anaesthesia can be achieved using propofol compared with midazolam, while depth of sedation was monitored with BIS monitor and OAA/S score. Both objective and clinical scoring correlate strongly during recovery from sedation.
PMCID: PMC4155284  PMID: 25197107
Bispectral index monitoring; midazolam; propofol; sedation; spinal anaesthesia
3.  Bispectral index score and observer's assessment of awareness/sedation score may manifest divergence during onset of sedation: Study with midazolam and propofol 
Indian Journal of Anaesthesia  2013;57(4):351-357.
Correlation between the clinical and electroencephalogram-based monitoring has been documented sporadically during the onset of sedation. Propofol and midazolam have been studied individually using the observer's assessment of awareness/sedation (OAA/S) score and Bispectral index score (BIS). The present study was designed to compare the time to onset of sedation for propofol and midazolam using both BIS and OAA/S scores, and to find out any correlation.
A total of 46 patients (18-60 years, either sex, American Society of Anesthesiologists (ASA) I/II) posted for infraumbilical surgeries under spinal anaesthesia were randomly allocated to receive either injection propofol 1 mg/kg bolus followed by infusion 3 mg/kg/h (Group P, n=23) or injection midazolam 0.05 mg/kg bolus followed by infusion 0.06 mg/kg/h (Group M, n=23). Spinal anaesthesia was given with 2.5 ml to 3.0 ml of 0.5% bupivacaine heavy. When sensory block reached T6 level, sedation was initiated. The time to reach BIS score 70 and time to achieve OAA/S score 3 from the start of study drug were noted. OAA/S score at BIS score 70 was noted. Data from 43 patients were analyzed using SPSS 12 for Windows.
Time to reach BIS score 70 using propofol was significantly lower than using the midazolam (P<0.05). Time to achieve OAA/S score 3 using propofol was comparable with midazolam (P=0.358).
A divergence exists between the time to reach BIS score 70 and time to achieve OAA/S score 3 using midazolam, compared with propofol, during the onset of sedation.
PMCID: PMC3800326  PMID: 24163448
Bispectral index score; midazolam; observer's assessment of awareness/sedation score; propofol; sedation
4.  Deep sedation during gastrointestinal endoscopy: Propofol-fentanyl and midazolam-fentanyl regimens 
AIM: To compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy.
METHODS: After obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observer’s assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ2 test, measurement of analysis of variance, and the κ statistic.
RESULTS: The times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination.
CONCLUSION: Deep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.
PMCID: PMC3683682  PMID: 23801836
Endoscopy; Deep sedation; Anesthetic administration; Anesthetic dose; Adverse effects
5.  Effect of Sub hypnotic Doses of Propofol and Midazolam for Nausea and Vomiting During Spinal Anesthesia for Cesarean Section 
Spinal anesthesia has been associated with intraoperative nausea and vomiting (IONV), especially during cesarean section, which is attributed to several mechanisms.
In the present study, therapeutic and preventive properties of sub hypnotic dose midazolam and propofol and their effects on the occurrence and severity of intraoperative nausea and vomiting during elective cesarean section under spinal anesthesia were evaluated.
Patients and Methods:
In a randomized, double-blind, and placebo-controlled clinical trial, 90 parturients, ASA class I and II, aged 20-30 years, who undergone spinal anesthesia for cesarean section were randomly allocated to one of three groups receiving midazolam (1 mg bolus and 0.1 mg/kg/hr, n=30), propofol (20 mg bolus and 0.1 mg/kg/hr, n = 30), and placebo (saline, n=30) intravenously (IV) immediately after umbilical cord clamping. Bupivacaine hydrochloride (10 mg) was used for induction of the anesthesia. Patients’ hemodynamics was monitored at 3-minute intervals. Furthermore, intraoperative and post-delivery emetic episodes, severity of emesis, scores of sedation and ephedrine consumption were recorded.
The incidence of nausea, retching, and vomiting was significantly higher in the control group compared to propofol and midazolam groups. Overall, PONV (postoperative nausea and vomiting) in midazolam group was as low as propofol group without any significant hemodynamic changes as seen in placebo group or even with propofol group.
Subhypnotic doses of midazolam or propofol are effective in the prevention of nausea and vomiting during and after cesarean section with spinal anesthesia and does not significantly influence hemodynamic of the patients.
PMCID: PMC4205801  PMID: 25346896
Propofol; Midazolam; Nausea; Vomiting; Cesarean section
6.  Comparison of dexmedetomidine and midazolam for monitored anesthesia care combined with tramadol via patient-controlled analgesia in endoscopic nasal surgery: A prospective, randomized, double-blind, clinical study 
Monitored anesthesia care (MAC) may be applied for septoplasty or endoscopic sinus surgery in which an adequate sedation and analgesia without respiratory depression are desired for comfort of both the patient and the surgeon. Several combinations with different agents have been used for this purpose in these patients. However, analgesic properties for these agents have not been reported.
The aim of this study was to investigate the analgesic and sedative effects of dexmedetomidine or midazolam infusion combined with tramadol that was used via patient-controlled analgesia (PCA), and to document the effects of these drugs on early cognitive functions.
This prospective, randomized, double-blind, clinical study enrolled patients undergoing septoplasty or endoscopic sinus surgery at the Abant Izzet Baysal University Hospital, Bolu, Turkey, between February and September 2006. Patients were randomly allocated in a 1:1 ratio into 1 of 2 groups: the dexmedetomidine group (group D) patients received IV dexmedetomidine 1 μg/kg for 10 minutes followed by continuous infusion of 0.5 μg/kg · h−1; and the midazolam group (group M) patients were administered a loading dose of IV midazolam 40 μg/kg for 10 minutes followed by infusion at the rate of 50 μg/kg · h−1. A 1-minute bolus dose of IV tramadol (1.5 mg/kg) was administered in both groups 10 minutes after the administration of the primary drug, and continued via infusion using a PCA device. After baseline measurements, systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR), oxygen saturation, and rate of respiration were recorded after the loading dose of study drug, after the bolus tramadol dose, at 10-minute intervals during the operation, and twice in the recovery rooms; 5 minutes after arrival and 5 minutes before discharge. Verbal rating score (VRS) and Ramsay sedation score were determined at baseline (after surgery was started), every 10 minutes thereafter until the end of the operation, and 2 times during recovery. All patients were assessed with the Wechsler Memory Scale-Revised at baseline (preoperatively) and 4 hours after the operation.
Seventy patients were enrolled in the study and randomly assigned to 1 of 2 groups: group D (sex, male/female, 23/12; mean [SEM] age, 32.53 [2.07] years; mean [SEM] weight, 73.03 [2.41] kg) or group M (sex, male/female, 21/14; mean [SEM] age, 34.43 [1.83] years; mean [SEM] weight, 67.90 [2.32] kg). All hemodynamic parameters (SAP, DAP, MAP, HR) were significantly higher in group M compared with group D from the onset of the surgery to discharge time (P < 0.05). Pain and sedation scores were similar in both groups, but the amount of PCA-administered rescue tramadol was significantly higher in group M (P = 0.001). A higher, though not statistically significant, prevalence of adverse events (ie, hypotension, bradycardia, and perioperative nausea and vomiting) were observed in group D. Postoperative logical verbal memory and digit span values were significantly higher in group D when compared with group M (P < 0.05). Postoperative digit span and visual reproduction scores were significantly higher than preoperative values in group D (P < 0.05). Postoperative personality functioning scores were significantly higher than preoperative values in group M (P < 0.05).
Based on VRS, Ramsay sedation scores, and surgeon and anesthesiologist satisfaction scores, dexmedetomidine or midazolam combined with tramadol PCA provided adequate analgesia and sedation in these adult patients undergoing septoplasty or endoscopic sinus surgery with MAC. A significantly larger amount of rescue tramadol was used by group M, suggesting that a better analgesic effect was achieved with dexmedetomidine.
PMCID: PMC3965987  PMID: 24678121
dexmedetomidine; midazolam; sedoanalgesia; cognitive function
7.  Comparison of Midazolam and Propofol for BIS-Guided Sedation During Regional Anaesthesia 
Indian Journal of Anaesthesia  2009;53(6):662-666.
Regional anaesthesia has become an important anaesthetic technique. Effective sedation is an essential for regional techniques too. This study compares midazolam and propofol in terms of onset & recovery from sedation, dosage and side effects of both the drugs using Bispectral Index monitoring. Ninety eight patients were randomly divided into two groups,one group recieved midazolam infusion while the other recieved propofol infusion until BIS reached 75. We observed Time to reach desired sedation, HR, MABP, time for recovery, dose to reach sedation and for maintenance of sedation and side effects if any. The time to reach required sedation was 11 min in Midazolam group(Group I) while it was 6 min in Propofol group(Group II) (p=0.0). Fall in MABP was greater with propofol. Recovery in with midazolam was slower than with propofol (18.6 ± 6.5 vs 10.10±3.65 min) (p=0.00). We concluded that both midazolam and propofol are effective sedatives, but onset and offset was quicker with propofol, while midazolam was more cardiostable.
PMCID: PMC2900075  PMID: 20640093
Propofol; Midazolam; Sedation; BIS
8.  Efficacy of intravenous midazolam versus clonidine as premedicants on bispectral index guided propofol induction of anesthesia in laparoscopic cholecystectomy: A randomized control trial 
Midazolam and clonidine are preferred premedicants whose effects are not restricted to the preoperative period. In addition, these premedicants significantly modulate not only the intraoperative requirements of the anesthetic agents, but also the postoperative outcome. We aim to compare the efficacy of both the agents in view of premedication, induction characteristics, hemodynamic changes and postoperative complications utilizing bispectral index (BIS) using propofol anesthesia.
Materials and Methods:
The type of this study was randomized control trial conducted on patients undergoing laparoscopic cholecystectomy under general anesthesia with endotracheal intubation. Study included 105 patients of either sex aged 20-60 years. The patients were randomly allocated into three groups: Intravenous midazolam (Group 1), clonidine (Group 2), and normal saline (Group 3) (control). The initial value of BIS and Ramsay Sedation Score, dose of propofol required for induction were noted in each group and monitored for pulse rate, electrocardiograph, noninvasive blood pressure, and BIS.
The requirement of propofol ranged from 40 to 150 mg. Mean requirement was maximum in Group 3 (109.43 ± 20.14 mg) and it was minimum in Group 1 (78.57 ± 22.15 mg). A significant reduction in consumption of propofol with the use of midazolam (P < 0.001) and clonidine (P < 0.001) was observed. Both premedicants partially attenuates laryngoscoy and intubation response along with reduction in the incidence of postoperative complications.
Both clonidine and midazolam contributed equally in lowering propofol consumption. Reduction in the induction dosage of propofol and hemodynamic variations were also observed to be similar with the use of midazolam or clonidine as premedicants. Both provide a beneficial effect in relation to recovery and less postoperative complications. However clonidine premedication was found to be more effective in preventing post operative shivering and can be recommended in routine practice.
PMCID: PMC4258972
Bispectral index; clonidine; dosage; midazolam; premedication
9.  Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study 
BMC Anesthesiology  2012;12:20.
ERCP practically requires moderate to deep sedation controlled by a combination of benzodiazepine and opiod. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and we hypothesized that it might decrease the risk of oversedation. We prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.
ERCP patients were randomized into 2 groups; the cocktail group (n = 103) and the controls (n = 102). For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.
In the cocktail group, the average administration rate of propofol was 6.2 mg/kg/hr. In the control group; average weight base dosage of meperidine and midazolam were 1.03 mg/kg and 0.12 mg/kg, respectively. Recovery times and patients’ satisfaction scores in the cocktail and control groups were 9.67 minutes and 12.89 minutes (P = 0.045), 93.1and 87.6 (P <0.001), respectively. Desaturation rates in the cocktail and conventional groups were 58.3% and 31.4% (P <0.001), respectively. All desaturations were corrected with temporary oxygen supplementation without the need for scope removal.
Cocktail sedation containing propofol provides faster recovery time and better patients’ satisfaction for patients undergoing ERCP. However, mild degree of desaturation may still develop.
Trial registration, NCT01540084
PMCID: PMC3434082  PMID: 22873637
Cocktail sedation containing propofol; Meperidine; Midazolam; ERCP
10.  Comparison of Clonidine and Midazolam Premedication Before Endoscopic Sinus Surgery: Results of Clinical Trial 
Premedication with clonidine has been found to reduce the bleeding during endoscopic sinus surgery (ESS), therefore lowering the risk of surgical complications. Premedication is an essential part of pre-surgical care and can potentially affect magnitude of systemic stress response to a surgical procedure. The aim of this study was to compare the efficacy of premedication with clonidine and midazolam in patients undergoing sinus surgery.
Forty-four patients undergoing ESS for chronic sinusitis and polyp removal were enrolled and randomly assigned to receive either oral clonidine or midazolam as a premedication before receiving propofol/remifentanil total intravenous anesthesia. The effect of this premedication choice on anesthetic requirements, intraoperative hemodynamic profile, preoperative anxiety and sedation as well as postoperative pain and shivering were examined in each premedication group.
Total intraoperative remifentanil requirement was lower in the clonidine group as compared to the midazolam group 503.2±147.0 µg vs. 784.5±283.8 µg, respectively (P<0.001). There was no difference between groups in required induction dose of propofol, level of preoperative anxiety, level of sedation and postoperative shivering. Intraoperative systemic blood pressure and heart rate response had a more favorable profile in patients premedicated with clonidine. Postoperative pain assessed by visual analogue scale for pain was lower in the clonidine group compared with to the midazolam premedication group.
Premedication with clonidine provides better attenuation of hemodynamic response and reduction of intraoperative remifentanil requirements in patients undergoing ESS. Postoperative pain seems to be better controlled after clonidine premedication as well.
PMCID: PMC4240489  PMID: 25436051
Anesthesia; Surgical procedures; Minimally invasive; Clonidine; Premedication
11.  Comparison of nasal Midazolam with Ketamine versus nasal Midazolam as a premedication in children 
Saudi Journal of Anaesthesia  2014;8(1):17-21.
This study was done to compare effects of intranasal midazolam and intranasal midazolam with ketamine for premedication of children aged 1-12 yrs undergoing intermediate and major surgeries.
Midazolam and Ketamine have already been used as premedicants in children. Our aim was to find out advantage of combination of midazolam with ketamine over midazolam by nasal route.
Sixty children of age group 1-12 yrs of American Society of Anesthesiologists (ASA) grade 1 and 2 were selected. Group A- midazolam (0.2 mg/kg), Group B- midazolam (0.15 mg/kg + ketamine 1 mg/kg). Both groups received drug intranasally 30 min before surgery in recovery room with monitored anesthesia care. Onset of sedation, sedation score, emotional reaction, intravenous cannula acceptance, and mask acceptance were studied.
Statistical Analysis:
Unpaired t test and chi square test.
Sedation score, anxiolysis, attitude, reaction to intravenous cannulation, face mask acceptance, and emotional reaction were significantly better in midazolam with ketamine group. Intra operatively, in both groups, pulse rate, oxygen saturation, and respiratory rate had no significant difference; also, post operatively, no significant difference was observed in above parameters, post operative analgesia was significantly better in midazolam with ketamine group.
Intra nasal premedication allows rapid and predictable sedation in children. Midazolam as well as combination of Midazolam with ketamine gives good level of sedation and comfort. But quality of sedation, analgesia, and comfort is significantly better in midazolam with ketamine group. No significant side effects were observed in both groups.
PMCID: PMC3950446  PMID: 24665234
Intranasal; Ketamine; midazolam; pediatric anesthesia
12.  Propofol versus Midazolam for Upper Gastrointestinal Endoscopy in Cirrhotic Patients: A Meta-Analysis of Randomized Controlled Trials 
PLoS ONE  2015;10(2):e0117585.
Sedation during gastrointestinal endoscopy is often achieved using propofol or midazolam in general population. However, impaired protein synthesis, altered drug metabolism, and compromised hepatic blood flow in patients with liver cirrhosis might affect the pharmacokinetics of sedatives, placing cirrhotic patients undergoing endoscopy at a greater risk of adverse events. The objective of this study was to assess comparative efficacies and safety of propofol and midazolam in cirrhotic patients undergoing endoscopy.
Randomized, controlled trials comparing propofol with midazolam in cirrhotic patients undergoing gastrointestinal endoscopy were selected. We performed the meta-analysis, using a random-effect model, the Review Manager, Version 5.2, statistical software package (Cochrane Collaboration, Oxford, UK) according to the PRISMA guidelines.
Five studies between 2003 and 2012, including 433 patients, were included. Propofol provided a shorter time to sedation (weight mean difference: -2.76 min, 95% confidence interval: -3.00 to -2.51) and a shorter recovery time (weight mean difference -6.17 min, 95% confidence interval: -6.81 to -5.54) than midazolam did. No intergroup difference in the incidence of hypotension, bradycardia, or hypoxemia was observed. Midazolam was associated with the deterioration of psychometric scores for a longer period than propofol.
This meta-analysis suggests that Propofol sedation for endoscopy provides more rapid sedation and recovery than midazolam does. The risk of sedation-related side effects for propofol does not differ significantly from that of midazolam. The efficacy of propofol in cirrhotic patients undergoing endoscopy is superior to those of midazolam.
PMCID: PMC4315567  PMID: 25646815
13.  Bispectral index monitoring as an adjunct to nurse-administered combined sedation during endoscopic retrograde cholangiopancreatography 
AIM: To determine whether bispectral index (BIS) monitoring is useful for propofol administration for deep sedation during endoscopic retrograde cholangiopancreatography (ERCP).
METHODS: Fifty-nine consecutive patients with a variety of reasons for ERCP who underwent the procedure at least twice between 1 July 2010 and 30 November 2010. This was a randomized cross-over study, in which each patient underwent ERCP twice, once with BIS monitoring and once with control monitoring. Whether BIS monitoring was done during the first or second ERCP procedure was random. Patients were intermittently administered a mixed regimen including midazolam, pethidine, and propofol by trained nurses. The nurse used a routine practice to monitor sedation using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale or the BIS monitoring. The total amount of midazolam and propofol used and serious side effects were compared between the BIS and control groups.
RESULTS: The mean total propofol dose administered was 53.1 ± 32.2 mg in the BIS group and 54.9 ± 30.8 mg in the control group (P = 0.673). The individual propofol dose received per minute during the ERCP procedure was 2.90 ± 1.83 mg/min in the BIS group and 3.44 ± 2.04 mg in the control group (P = 0.103). The median value of the MOAA/S score during the maintenance phase of sedation was comparable for the two groups. The mean BIS values throughout the procedure (from insertion to removal of the endoscope) were 76.5 ± 8.7 for all 59 patients in using the BIS monitor. No significant differences in the frequency of < 80% oxygen saturation, hypotension (< 80 mmHg), or bradycardia (< 50 beats/min) were observed between the two study groups. Four cases of poor cooperation occurred, in which the procedure should be stopped to add the propofol dose. After adding the propofol, the procedure could be conducted successfully (one case in the BIS group, three cases in the control group). The endoscopist rated patient sedation as excellent for all patients in both groups. All patients in both groups rated their level of satisfaction as high (no discomfort). During the post-procedural follow-up in the recovery area, no cases of clinically significant hypoxic episodes were recorded in either group. No other postoperative side effects related to sedation were observed in either group.
CONCLUSION: BIS monitoring trend to slighlty reduce the mean propofol dose. Nurse-administered propofol sedation under the supervision of a gastroenterologist may be considered an alternative under anesthesiologist.
PMCID: PMC3501778  PMID: 23180950
Conscious sedation; Bispectral index monitors; Pancreatic neoplasm; Endoscopic retrograde cholangiopancreatography
14.  Comparison between Midazolam Used Alone and in Combination with Propofol for Sedation during Endoscopic Retrograde Cholangiopancreatography 
Clinical Endoscopy  2014;47(1):94-100.
Endoscopic retrograde cholangiopancreatography (ERCP) is an uncomfortable procedure that requires adequate sedation for its successful conduction. We investigated the efficacy and safety of the combined use of intravenous midazolam and propofol for sedation during ERCP.
A retrospective review of patient records from a single tertiary care hospital was performed. Ninety-four patients undergoing ERCP received one of the two medication regimens, which was administered by a nurse under the supervision of a gastroenterologist. Patients in the midazolam (M) group (n=44) received only intravenous midazolam, which was titrated to achieve deep sedation. Patients in the midazolam pulse propofol (MP) group (n=50) initially received an intravenous combination of midazolam and propofol, and then propofol was titrated to achieve deep sedation.
The time to the initial sedation was shorter in the MP group than in the M group (1.13 minutes vs. 1.84 minutes, respectively; p<0.001). The recovery time was faster in the MP group than in the M group (p=0.031). There were no significant differences between the two groups with respect to frequency of adverse events, pain experienced by the patient, patient discomfort, degree of amnesia, and gag reflex. Patient cooperation, rated by the endoscopist as excellent, was greater in the MP group than in the M group (p=0.046).
The combined use of intravenous midazolam and propofol for sedation during ERCP is more effective than midazolam alone. There is no difference in the safety of the procedure.
PMCID: PMC3928499  PMID: 24570889
Propofol; Midazolam; Cholangiopancreatography, endoscopic retrograde; Conscious sedation
15.  Comparison between propofol and dexmedetomidine on depth of anesthesia: A prospective randomized trial 
Background and Aims:
Intravenous agents such as propofol are commonly used to maintain adequate depth of anesthesia. Dexmedetomidine which has an anesthetic sparing effect is being considered for maintaining intraoperative depth of anesthesia. We hypothesized to compare the effect of dexmedetomidine on depth of anesthesia with propofol and evaluated whether dexmedetomidine can be used as sole anesthetic agent in maintaining depth of anesthesia.
Materials and Methods:
Sixty patients of ASA PS I, 18-65 years of age, scheduled for laparotomy under general anesthesia were randomly divided into two groups of 30 each. Group A received propofol 1 mg/kg bolus followed by infusion (50 mcg/kg/min) and Group B received dexmedetomidine 1 mcg/kg bolus followed by infusion (0.5 mcg/kg/h). Both the groups were administered standard general anesthesia with routine monitoring along with Bispectral index (BIS) and values were recorded at intervals of 10 min. In all patients Ramsay sedation score was recorded after extubation and they were assessed for recall of intraoperative events using Modified Brice questionnaire.
Heart rate and mean arterial pressure were less in Group B than Group A. Intraoperative BIS values were significantly lower in Group B (P < 0.0001). Although sedation score was more in Group B it did not prolong recovery. No recall was found in any patient.
Dexmedetomidine was comparable with propofol in maintaining anesthesia and it can produce better control of hemodynamics and BIS value. Thus dexmedetomidine can be used as the sole maintenance anesthetic agent.
PMCID: PMC4234794  PMID: 25425783
BIS; Bispectral index; dexmedetomidine; propofol; recall; sedation score
16.  Intravenous sedation for ocular surgery under local anaesthesia. 
Anterior segment ophthalmic surgery is commonly performed under local anaesthesia. In order to improve patient comfort, a variety of sedation techniques has been employed in the past. The object of this study was, firstly, to determine whether continuous intravenous sedation during surgery offered any advantages in patients premedicated with temazepam and metoclopramide, and, secondly, to compare midazolam to propofol for this purpose. Forty nine patients were randomly allocated to receive no intravenous sedation (n = 15), continuous propofol infusion (n = 17), or continuous intravenous midazolam infusion (n = 17) after peribulbar anaesthesia. Each technique provided cardiovascular and respiratory stability and allowed early recovery with minimal postoperative sequelae. Unexpected ocular field movement occurred more commonly in the patients receiving intravenous sedation, although statistical significance was not shown (p = 0.06). Significantly more patients in the intravenous sedation groups reported amnesia (p = 0.03). Patient acceptability was good irrespective of the technique used. This study suggests that continuous sedation using propofol or midazolam is not beneficial and should be avoided in ophthalmic patients who have received a simple premedication.
PMCID: PMC505230  PMID: 1420042
17.  Preanesthetic medication in children: A comparison of intranasal dexmedetomidine versus oral midazolam 
Saudi Journal of Anaesthesia  2011;5(4):387-391.
Relieving preoperative anxiety is an important concern for the pediatric anesthesiologist. Midazolam has become the most frequently used premedication in children. However, new drugs such as the α2 -agonists have emerged as alternatives for premedication in pediatric anesthesia.
One hundred and twenty children scheduled for adenotonsillectomy were enrolled in this prospective, double-blind, randomized study. The children were divided into two equal groups to receive either intranasal dexmedetomidine 1 μg/kg (group D), or oral midazolam 0.5 mg/kg (group M) at approximately 60 and 30 mins, respectively, before induction of anesthesia. Preoperative sedative effects, anxiety level changes, and the ease of child-parent separation were assessed. Also, the recovery profile and postoperative analgesic properties were assessed.
Children premedicated with intranasal dexmedetomidine achieved significantly lower sedation levels (P=0.042), lower anxiety levels (P=0.036), and easier child-parent separation (P=0.029) than children who received oral midazolam at the time of transferring the patients to the operating room. Postoperatively, the time to achieve an Aldrete score of 10 was similar in both the groups (P=0.067). Also, the number of children who required fentanyl as rescue analgesia medication was significantly less (P=0.027) in the dexmedetomidine group.
Intranasal dexmedetomidine appears to be a better choice for preanesthetic medication than oral midazolam in our study. Dexmedetomidine was associated with lower sedation levels, lower anxiety levels, and easier child-parent separation at the time of transferring patients to the operating room than children who received oral midazolam. Moreover, intranasal dexmedetomidine has better analgesic property than oral midazolam with discharge time from postanesthetic care unit similar to oral midazolam.
PMCID: PMC3227308  PMID: 22144926
Dexmedetomidine; midazolam; pediatric; sedation
18.  Dexmedetomidine use in the ICU: Are we there yet? 
Critical Care  2013;17(3):320.
Expanded abstract
Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedeto midine for Long-Term Sedation Investigators: Dexmedetomidine vesus midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA 2012, 307:1151-1160.
Long-term sedation with midazolam or propofol in intensive care units (ICUs) has serious adverse effects. Dexmedetomidine, an alpha-2 agonist available for ICU sedation, may reduce the duration of mechanical ventilation and enhance patient comfort.
The objective was to determine the efficacy of dexmedetomidine versus midazolam or propofol (preferred usual care) in maintaining sedation, reducing duration of mechanical ventilation, and improving patients' interaction with nursing care.
Two phase 3 multicenter, randomized, double-blind trials were conducted.
The MIDEX (Midazolam vs. Dexmedetomidine) trial compared midazolam with dexmedetomidine in ICUs of 44 centers in nine European countries. The PRODEX (Propofol vs. Dexmedetomidine) trial compared propofol with dexmedetomidine in 31 centers in six European countries and two centers in Russia.
The subjects were adult ICU patients who were receiving mechanical ventilation and who needed light to moderate sedation for more than 24 hours.
After enrollment, 251 and 249 subjects were randomly assigned midazolam and dexmedetomidine, respectively, in the MIDEX trial, and 247 and 251 subjects were randomly assigned propofol and dexmedetomidine, respectively, in the PRODEX trial. Sedation with dexmedetomidine, midazolam, or propofol; daily sedation stops; and spontaneous breathing trials were employed.
For each trial, investigators tested whether dexmedetomidine was noninferior to control with respect to proportion of time at target sedation level (measured by Richmond Agitation Sedation Scale) and superior to control with respect to duration of mechanical ventilation. Secondary end points were the ability of the patient to communicate pain (measured by using a visual analogue scale [VAS]) and length of ICU stay. Time at target sedation was analyzed in per-protocol (midazolam, n = 233, versus dexmedetomidine, n = 227; propofol, n = 214, versus dexmedetomidine, n = 223) population.
Dexmedetomidine/midazolam ratio in time at target sedation was 1.07 (95% confidence interval (CI) 0.97 to 1.18), and dexmedetomidine/propofol ratio in time at target sedation was 1.00 (95% CI 0.92 to 1.08). Median duration of mechanical ventilation appeared shorter with dexmedetomidine (123 hours, interquartile range (IQR) 67 to 337) versus midazolam (164 hours, IQR 92 to 380; P = 0.03) but not with dexmedetomidine (97 hours, IQR 45 to 257) versus propofol (118 hours, IQR 48 to 327; P = 0.24). Patient interaction (measured by using VAS) was improved with dexmedetomidine (estimated score difference versus midazolam 19.7, 95% CI 15.2 to 24.2; P <0.001; and versus propofol 11.2, 95% CI 6.4 to 15.9; P <0.001). Lengths of ICU and hospital stays and mortality rates were similar. Dexmedetomidine versus midazolam patients had more hypotension (51/247 [20.6%] versus 29/250 [11.6%]; P = 0.007) and bradycardia (35/247 [14.2%] versus 13/250 [5.2%]; P <0.001).
Among ICU patients receiving prolonged mechanical ventilation, dexmedetomidine was not inferior to midazolam and propofol in maintaining light to moderate sedation. Dexmedetomidine reduced duration of mechanical ventilation compared with midazolam and improved the ability of patients to communicate pain compared with midazolam and propofol. Greater numbers of adverse effects were associated with dexmedetomidine.
PMCID: PMC3706806  PMID: 23731973
19.  Comparative evaluation of midazolam and clonidine as pediatric oral premedication 
Clonidine provides many desirable effects like sedation, analgesia, anxiolysis, and hemodynamic stability and these properties make it a potentially useful anesthetic premedication in the pediatric settings. The aim of this study was to compare oral midazolam (0.5 mg/kg), which is considered gold standard with oral clonidine (5 mcg/kg) as a premedication in pediatric patients.
Materials and Methods:
Sixty children classified as American Society of Anesthesiologists physical status I, aged between 2 and 12, who were scheduled to undergo an elective surgery, were enrolled for a prospective, randomized, and double blind controlled trial. They received either oral midazolam (Group M) or oral clonidine (Group C) 60 minutes before induction of anesthesia and were submitted to an evaluation of anxiety and sedation scores. We also evaluated secondary outcomes such as palatability, parental separation, effect on hemodynamic status, co-operation during venipuncture and facemask application, postoperative analgesic requirement, and recovery profile.
Oral midazolam had better efficacy in the preoperative period as sedative and anxiolytic (P < 0.001), allowed better cooperation during venipuncture and facemask application (P < 0.001), whereas, oral clonidine provided better palatability (P < 0.001), parental satisfaction (P < 0.001), stable perioperative hemodynamics (P < 0.001), better postoperative analgesia (P < 0.001), and night sleep pattern (P < 0.05) without any noticeable side effects (P > 0.05).
We conclude that under the conditions of this study, oral midazolam is a better medication than clonidine in children in preoperative period while clonidine is a better medication postoperatively with added advantage of palatability, hemodynamic stability, and no significant side effects.
PMCID: PMC4173523
Anxiolytics; oral clonidine; oral midazolam; pediatric anesthesia; premedication; sedation
20.  Comparative evaluation of recovery characteristics of fentanyl and butorphanol when used as supplement to propofol anaesthesia 
Background and Aim:
Narcotics have been used since long as a component of balanced anaesthesia, thus minimizing the anaesthetic requirement both during induction and maintenance as well as attenuating the pressor response during laryngoscopy and intubation. Equally significant is their role in provision of smoother recovery period by minimizing postoperative pain. Other than pain, the factors like postoperative nausea and vomiting (PONV), shivering, sedation and respiratory depression are equally important in recovery from the effects of anaesthetic drugs. The present study aimed at comparing the postoperative recovery characterstics of fentanyl and butorphanol in patients undergoing open cholecystectomy under general anaesthesia.
Materials and Methods:
The present study configured one hundred adults patients of American Society of Anaesthesiologists (ASA) grade 1 or 2 of either sex scheduled to undergo elective open cholecystectomy and were randomly assigned to receive fentanyl (group F; n = 50) or butorphanol (group B; n = 50). Both group were premedicated with midazolam 0.04 mg/kg intravenously followed by injection fentanyl 2 mcg/kg or butorphanol 40 mcg/kg. Standard induction was done with propofol 2 mg/kg and vecuronium 0.1 mg/kg was used for intubation. Anaesthesia was maintained with propofol infusion and 67% nitrous oxide in oxygen. Intraoperative hemodynamic parameters were observed and recorded. Postoperatively analgesia, sedation, PONV, shivering, respiratory depression and recovery score were observed.
The recovery time was less in group F (P > 0.05) while post operative analgesia (P < 0.001) and sedation (P > 0.05) was more in group B. The incidence of respiratory depression was more in group B (P > 0.05). PONV was comparable in both the groups. Postoperative shivering was significantly low in group B (P < 0.05).
It is concluded that besides easy availability and lower cost, butorphanol decreased propofol consumption intraoperatively and provided better analgesia and prophylaxis against shivering in postoperative period.
PMCID: PMC3678702  PMID: 23776820
Butorphanol; fentanyl; propofol; recovery
21.  Sedative Efficacy of Propofol in Patients Intubated/Ventilated after Coronary Artery Bypass Graft Surgery 
Sedation after open heart surgery is important in preventing stress on the heart. The unique sedative features of propofol prompted us to evaluate its potential clinical role in the sedation of post-CABG patients.
To compare propofol-based sedation to midazolam-based sedation after coronary artery bypass graft (CABG) surgery in the intensive care unit (ICU).
Patients and Methods:
Fifty patients who were admitted to the ICU after CABG surgery was randomized into two groups to receive sedation with either midazolam or propofol infusions; and additional analgesia was administered if required. Inclusion criteria were as follows: patients 40-60 years old, hemodynamic stability, ejection fraction (EF) more than 40%; exclusion criteria included patients who required intra-aortic balloon pump or inotropic drugs post-bypass. The same protocol of anesthetic medications was used in both groups. Depth of sedation was monitored using the Ramsay sedation score (RSS). Invasive mean arterial pressure (MAP) and heart rate (HR), arterial blood gas (ABG) and ventilatory parameters were monitored continuously after the start of study drug and until the patients were extubated.
The depth of sedation was almost the same in the two groups (RSS=4.5 in midazolam group vs 4.7 in propofol group; P = 0.259) but the total dose of fentanyl in the midazolam group was significantly more than the propofol group (12.5 mg/hr vs 4 mg/hr) (P = 0.0039). No significant differences were found in MAP (P = 0.51) and HR (P = 0.41) between the groups. The mean extubation time in patients sedated with propofol was shorter than those sedated with midazolam (102 ± 27 min vs 245 ± 42 min, respectively; P < 0.05) but the ICU discharge time was not shorter (47.5 hr vs 36.3 hr, respectively; P = 0.24).
Propofol provided a safe and acceptable sedation for post-CABG surgical patients, significantly reduced the requirement for analgesics, and allowed for more rapid tracheal extubation than midazolam but did not result in earlier ICU discharge.
PMCID: PMC3961039  PMID: 24660162
Propofol; Analgesics; Coronary Artery Bypass; Deep Sedation; Midazolam; Airway Extubation; Length of Stay
22.  Comparison of Propofol-Remifentanil Versus Propofol-Ketamine Deep Sedation for Third Molar Surgery 
Anesthesia Progress  2012;59(3):107-117.
This study aimed to compare continuous intravenous infusion combinations of propofol-remifentanil and propofol-ketamine for deep sedation for surgical extraction of all 4 third molars. In a prospective, randomized, double-blinded controlled study, participants received 1 of 2 sedative combinations for deep sedation for the surgery. Both groups initially received midazolam 0.03 mg/kg for baseline sedation. The control group then received a combination of propofol-remifentanil in a ratio of 10 mg propofol to 5 μg of remifentanil per milliliter, and the experimental group received a combination of propofol-ketamine in a ratio of 10 mg of propofol to 2.5 mg of ketamine per milliliter; both were given at an initial propofol infusion rate of 100 μg/kg/min. Each group received an induction loading bolus of 500 μg/kg of the assigned propofol combination along with the appropriate continuous infusion combination . Measured outcomes included emergence and recovery times, various sedation parameters, hemodynamic and respiratory stability, patient and surgeon satisfaction, postoperative course, and associated drug costs. Thirty-seven participants were enrolled in the study. Both groups demonstrated similar sedation parameters and hemodynamic and respiratory stability; however, the ketamine group had prolonged emergence (13.6 ± 6.6 versus 7.1 ± 3.7 minutes, P = .0009) and recovery (42.9 ± 18.7 versus 24.7 ± 7.6 minutes, P = .0004) times. The prolonged recovery profile of continuously infused propofol-ketamine may limit its effectiveness as an alternative to propofol-remifentanil for deep sedation for third molar extraction and perhaps other short oral surgical procedures, especially in the ambulatory dental setting.
PMCID: PMC3468288  PMID: 23050750
Propofol; Ketamine; Remifentanil; Deep sedation; TIVA
23.  Evaluation of propofol anesthesia in morbidly obese children and adolescents 
BMC Anesthesiology  2013;13:8.
Poor characterization of propofol pharmacokinetics and pharmacodynamics in the morbidly obese (MO) pediatric population poses dosing challenges. This study was conducted to evaluate propofol total intravenous anesthesia (TIVA) in this population.
After IRB approval, a prospective study was conducted in 20 MO children and adolescents undergoing laparoscopic surgery under clinically titrated propofol TIVA. Propofol doses/infusion rates, hemodynamic variables, times to induction and emergence, and postoperative occurrence of respiratory adverse events (RAE) were recorded, along with intraoperative blinded Bispectral Index/BIS and postoperative Ramsay sedation scores (RSS). Study subjects completed awareness questionnaires on postoperative days 1 and 3. Propofol concentrations were obtained at predetermined intra- and post-operative time points.
Study subjects ranged 9 – 18 years (age) and 97 - 99.9% (BMI for age percentiles). Average percentage variability of hemodynamic parameters from baseline was ≈ 20%. Patients had consistently below target BIS values (BIS < 40 for >90% of maintenance phase), delayed emergence (25.8 ± 22 minutes), increased somnolence (RSS ≥ 4) in the first 30 minutes of recovery from anesthesia and 30% incidence of postoperative RAE, the odds for which increased by 14% per unit increase in BMI (p ≤ 0.05). Mean propofol concentration was 6.2 mg/L during maintenance and 1.8 mg/L during emergence from anesthesia.
Our findings indicate clinical overestimation of propofol requirements and highlight the challenges of clinically titrated propofol TIVA in MO adolescents. In this setting, it may be advantageous to titrate propofol to targeted BIS levels until more accurate weight-appropriate dosing regimens are developed, to minimize relative overdosing and its consequences.
PMCID: PMC3644256  PMID: 23602008
Morbidly obese; Bariatric; Propofol; Total intravenous anesthesia; Bispectral index; Anesthetic depth; Pediatric; Adolescents
24.  Comparison between the recovery time of alfentanil and fentanyl in balanced propofol sedation for gastrointestinal and colonoscopy: a prospective, randomized study 
BMC Gastroenterology  2012;12:164.
There is increasing interest in balanced propofol sedation (BPS) titrated to moderate sedation (conscious sedation) for endoscopic procedures. However, few controlled studies on BPS targeted to deep sedation for diagnostic endoscopy were found. Alfentanil, a rapid and short-acting synthetic analog of fentanyl, appears to offer clinically significant advantages over fentanyl during outpatient anesthesia.
It is reasonable to hypothesize that low dose of alfentanil used in BPS might also result in more rapid recovery as compared with fentanyl.
A prospective, randomized and double-blinded clinical trial of alfentanil, midazolam and propofol versus fentanyl, midazolam and propofol in 272 outpatients undergoing diagnostic esophagogastroduodenal endoscopy (EGD) and colonoscopy for health examination were enrolled. Randomization was achieved by using the computer-generated random sequence. Each combination regimen was titrated to deep sedation. The recovery time, patient satisfaction, safety and the efficacy and cost benefit between groups were compared.
260 participants were analyzed, 129 in alfentanil group and 131 in fentanyl group. There is no significant difference in sex, age, body weight, BMI and ASA distribution between two groups. Also, there is no significant difference in recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between two groups. Though deep sedation was targeted, all cardiopulmonary complications were minor and transient (10.8%, 28/260). No serious adverse events including the use of flumazenil, assisted ventilation, permanent injury or death, and temporary or permanent interruption of procedure were found in both groups. However, fentanyl is New Taiwan Dollar (NT$) 103 (approximate US$ 4) cheaper than alfentanil, leading to a significant difference in total cost between two groups.
This randomized, double-blinded clinical trial showed that there is no significant difference in the recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between the two most common sedation regimens for EGD and colonoscopy in our hospital. However, fentanyl is NT$103 (US$ 4) cheaper than alfentanil in each case.
Trial registration
Institutional Review Board of Buddhist Tzu Chi General Hospital (IRB097-18) and Chinese Clinical Trial Registry (ChiCTR-TRC-12002575)
PMCID: PMC3607964  PMID: 23170921
Balanced propofol sedation; Alfentanil; Fentanyl; Deep sedation; Diagnostic endoscopy; Cost benefit
25.  Sedation Depth During Spinal Anesthesia and the Development of Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Repair 
Mayo Clinic Proceedings  2010;85(1):18-26.
OBJECTIVE: To determine whether limiting intraoperative sedation depth during spinal anesthesia for hip fracture repair in elderly patients can decrease the prevalence of postoperative delirium.
PATIENTS AND METHODS: We performed a double-blind, randomized controlled trial at an academic medical center of elderly patients (≥65 years) without preoperative delirium or severe dementia who underwent hip fracture repair under spinal anesthesia with propofol sedation. Sedation depth was titrated using processed electroencephalography with the bispectral index (BIS), and patients were randomized to receive either deep (BIS, approximately 50) or light (BIS, ≥80) sedation. Postoperative delirium was assessed as defined by Diagnostic and Statistical Manual of Mental Disorders (Third Edition Revised) criteria using the Confusion Assessment Method beginning at any time from the second day after surgery.
RESULTS: From April 2, 2005, through October 30, 2008, a total of 114 patients were randomized. The prevalence of postoperative delirium was significantly lower in the light sedation group (11/57 [19%] vs 23/57 [40%] in the deep sedation group; P=.02), indicating that 1 incident of delirium will be prevented for every 4.7 patients treated with light sedation. The mean ± SD number of days of delirium during hospitalization was lower in the light sedation group than in the deep sedation group (0.5±1.5 days vs 1.4±4.0 days; P=.01).
CONCLUSION: The use of light propofol sedation decreased the prevalence of postoperative delirium by 50% compared with deep sedation. Limiting depth of sedation during spinal anesthesia is a simple, safe, and cost-effective intervention for preventing postoperative delirium in elderly patients that could be widely and readily adopted.
Trial Registration: Identifier: NCT00590707
Use of light propofol sedation decreased the prevalence of postoperative delirium by 50% compared with deep sedation. Limiting depth of sedation during spinal anesthesia is a simple, safe, and cost-effective intervention for preventing postoperative delirium in elderly patients that could be widely and readily adopted.
PMCID: PMC2800291  PMID: 20042557

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