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1.  Safe and effective use of conscious sedation for defibrillation threshold testing during ICD implantation 
Background
Over a period of years general anesthesia has been a standard anesthetic technique for defibrillation threshold (DFT) testing at the time of implant. DFT testing without general anesthesia cover has gained limited acceptance. Use of local anesthesia combined with deep sedation for DFT testing might facilitate and simplify these procedures by reducing the procedural time, staff time, avoiding inefficient service in organizing anesthetic cover; thereby improving patient compliance.
Objective
The objective of this study was to evaluate feasibility, safety and efficacy of conscious sedation for DFT testing during Implantable cardioverter defibrillators (ICD) implantation.
Method
Data of 87 non-selected patients who achieved adequate sedation with titrated doses of midazolam and pethidine were analyzed retrospectively. These medications were administered by a circulating nurse under the supervision of the implanting physicians. All hemodynamic measures, treatment and complications were monitored and recorded throughout the procedure.
Results
A retrospective analysis of data from 87 patients who underwent ICD implantation and DFT testing under conscious sedation at our center was reported. The mean dose of midazolam and pethidine administered was 4.9 ± 1.8 and 47.7 ± 20 mg, respectively. During the period of conscious sedation, no patient depicted episode of sustained apnea. No major complication or mortality was reported.
Conclusion
Use of conscious sedation as an alternative to the use of general anesthesia for DFT testing during ICD implantation is found to be feasible, safe and effective, with an added advantage of reduced procedural time and improved patient compliance.
doi:10.1016/j.jsha.2010.07.004
PMCID: PMC3727476  PMID: 23960622
Conscious sedation; Defibrillation threshold testing; Implantable cardioverter defibrillators
2.  Unsedated transnasal endoscopy: A Canadian experience in daily practice 
BACKGROUND:
Esophagogastroduodenoscopy (EGD) is the most frequently performed diagnostic procedure for upper gastrointestinal disorders. The procedure is routinely performed under conscious sedation in North America. A significant proportion of morbidity and mortality associated with EGD is related to hypoxia due to conscious sedation. The use of sedation is also associated with an increase in cost, loss of work on the day of endoscopy and the need for the patient to be accompanied home after the procedure. Transnasal endoscopy has advantages such as no sedation and less patient monitoring, nursing time and expenses than conventional per oral EGD.
OBJECTIVES:
To assess the feasibility and acceptability of unsedated transnasal EGD in daily practice.
METHODS:
Patients due to undergo EGD were given a choice of either unsedated transnasal EGD or per oral EGD with sedation. Patients who chose unsedated transnasal EGD had the procedure performed in the office by a senior gastroenterologist with experience in transnasal EGD. All procedures were performed using a small-calibre esophagogastroduodenoscope. All patients were surveyed using a patient satisfaction questionnaire, and were asked to give specific scores in terms of choking sensation, sore throat, nasal discomfort and abdominal discomfort. All variables were assessed by scores between 0 and 10, with 10 indicating the most severe degree of each variable. Any complications were also recorded.
RESULTS:
Between March 2002 and August 2003, 231 patients underwent transnasal EGD. The median age of the patients was 57 years (range 15 to 87 years). Complete examinations were possible in 98% of patients. Patients reported a high degree of acceptability (mean score 6.6, range 1 to 10) and low degrees of choking sensation (mean 1.8, range 0 to 10), nasal discomfort (mean 1.7, range 0 to 10), sore throat (mean 0.8, range 0 to 9) and abdominal discomfort (mean 1.1, range 0 to 10). The only complications reported by the patients were epistaxis (n=2, 0.9%) and sinusitis (n=1, 0.4%). Some patients also reported transient light-headedness (n=12, 5%) and mucous discharge (n=2, 0.9%). When asked, 185 patients (88%) stated that they were willing to undergo the same procedure in the future if medically indicated. Of the 84 patients who had conventional EGD under conscious sedation in the past, 52 patients (62%) preferred transnasal EGD without sedation.
CONCLUSIONS:
Transnasal EGD is generally well tolerated, feasible and safe. It can be performed with topical anesthesia in an outpatient setting. The low complication rate, high patient satisfaction and potential cost savings make transnasal endoscopy an attractive alternative to conventional EGD to screen patients for upper gastrointestinal tract diseases.
PMCID: PMC2662198  PMID: 18354752
EGD; Sedation; Transnasal endoscopy
3.  Evaluation of the SEDline to improve the safety and efficiency of conscious sedation 
Brain function monitors have improved safety and efficiency in general anesthesia; however, they have not been adequately tested for guiding conscious sedation for periodontal surgical procedures. This study evaluated the patient state index (PSI) obtained from the SEDline monitor (Sedline Inc., San Diego, CA) to determine its capacity to improve the safety and efficiency of intravenous conscious sedation during outpatient periodontal surgery. Twenty-one patients at the periodontics clinic of Baylor College of Dentistry were admitted to the study in 2009 and sedated to a moderate level using midazolam and fentanyl during periodontal surgery. The PSI monitoring was blinded from the clinician, and the following data were collected: vital signs, Ramsay sedation scale (RSS), medications administered, adverse events, PSI, electroencephalography, and the patients' perspective through visual analogue scales. The data were correlated to evaluate the PSI's ability to assess the level of sedation. Results showed that the RSS and PSI did not correlate (r = −0.25) unless high values associated with electromyographical (EMG) activity were corrected (r = −0.47). Oxygen desaturation did not correlate with the PSI (r = −0.08). Satisfaction (r = −0.57) and amnesia (r = −0.55) both increased as the average PSI decreased. In conclusion, within the limits of this study, PSI appears to correlate with amnesia, allowing a practitioner to titrate medications to that effect. It did not provide advance warning of adverse events and had inherent inaccuracies due to EMG activity during oral surgery. The PSI has the potential to increase safety and efficiency in conscious sedation but requires further development to eliminate EMG activity from confounding the score.
PMCID: PMC3124903  PMID: 21738291
4.  Esophagogastroduodenoscopy with conscious sedation does not interfere with catheter-based 24-h pH monitoring 
AIM: To investigate the impact of esophagogastroduodenoscopy with conscious sedation on the subsequent 24-h catheter-based pH monitoring.
METHODS: Fifty patients with extra-esophageal symptoms of gastroesophageal reflux disease undergoing ambulatory dual-probe 24-h pH monitoring were enrolled from March 2010 to August 2011. All of the data were collected prospectively and analyzed retrospectively. Thirty-six patients (72%, group A) underwent pH monitoring shortly after esophagogastroduodenoscopy (EGD) with conscious sedation, and 14 patients (28%, group B) underwent pH monitoring without conscious sedation. The 24-h pH data from two time periods were analyzed: the first 4 h (Period I) and the remaining time of the study (Period II).
RESULTS: The mean age of the patients was 49.6 ± 12.5 years; 20 patients (40%) were men. The baseline data, including age, sex, body mass index, reflux esophagitis, the Reflux Symptom Index, and the Reflux Findings Score, were comparable between the two groups. The percentage of total time with a pH < 4 and the frequency of acid reflux during Period I were not significantly different between the two groups, as measured using both pharyngeal (0.03% ± 0.10% vs 0.07% ± 0.16%, P = 0.32; and 0.07 ± 0.23 episodes/h vs 0.18 ± 0.47 episodes/h, P = 0.33, respectively) and esophageal probes (0.96% ± 1.89% vs 0.42% ± 0.81%, P = 0.59; and 0.74 ± 1.51 episodes/h vs 0.63 ± 0.97 episodes/h, P = 0.49, respectively). The percentage of total time with a pH < 4 and the frequency of acid reflux were also not significantly different between Periods I and II in group A patients, as measured using both pharyngeal (0.03% ± 0.10% vs 0.23% ± 0.85%, P = 0.21; and 0.07 ± 0.23 episodes/h vs 0.29 ± 0.98 episodes/h, P = 0.22, respectively) and esophageal probes (0.96% ± 1.89% vs 1.11% ± 2.57%, P = 0.55; and 0.74 ± 1.51 episodes/h vs 0.81 ± 1.76 episodes/h, P = 0.55, respectively).
CONCLUSION: EGD with conscious sedation does not interfere with the results of subsequent 24-h pH monitoring in patients with extra-esophageal symptoms of gastroesophageal reflux disease.
doi:10.3748/wjg.v19.i11.1805
PMCID: PMC3607757  PMID: 23555169
Esophagogastroduodenoscopy; Conscious sedation; pH monitoring; Gastroesophageal reflux disease; Extraesophageal symptoms
5.  Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial 
BMC Gastroenterology  2013;13:176.
Background
Endoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection. These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis. The aim of this trial is to determine the safety and effectiveness of dexmedetomidine sedation compared to the standard used propofol TCI sedation during endoscopic oesophageal interventions.
Methods
The study will be performed as a randomized controlled trial. The first 64 consenting patients will be randomized to either the propofol or the dexmedetomidine group. Following endoscopy patients and gastroenterologists have to fill in questionnaires (PSSI, CSSI) (see abbreviations) about their sedation experiences. Additionally, patients have to accomplish the Trieger test before and after the procedure. Patient monitoring includes time adapted HR, SO2, ECG, NIBP, exCO2, NICO, sweat conductance measurement, OAA/S, and the Aldrete score. Effectiveness of sedation, classified by satisfaction levels and pain and sedation score measured by questionnaires is the primary outcome parameter. Respiratory and hemodynamic complications are surrogate parameters for the secondary outcome parameter “safety”.
Discussion
The acceptance level among patients after propofol sedation is high. Dexmedetomidine is a relatively new representative for procedural sedation. Has this new form of conscious sedation the potential to be safer and more effective for patients and endoscopists than propofol during endoscopic oesophageal interventions?
Trial registration
This trial is registered in the ISRCTN Register (ISRCTN 68599804). It will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Departments of Anesthesiology and Gastroenterology & Hepatology of the Academic Medical Center of Amsterdam are responsible for the design and conduct of the trial.
doi:10.1186/1471-230X-13-176
PMCID: PMC3922843  PMID: 24377675
Procedural sedation; Dexmedetomidine; Endoscopic oesophageal intervention
6.  Magnetic imaging-assisted colonoscopy vs conventional colonoscopy: A randomized controlled trial 
World Journal of Gastroenterology : WJG  2014;20(36):13178-13184.
AIM: To compare magnetic imaging-assisted colonoscopy (MIC) with conventional colonoscopy (CC).
METHODS: Magnetic imaging technology provides a computer-generated image of the shape and position of the colonoscope onto a monitor to give visual guidance to the endoscopist. It is designed to improve colonoscopy performance and tolerability for patients by enabling visualization of loop formation and endoscope position. Recently, a new version of MIC technology was developed for which there are limited data.To evaluate this latest generation of MIC among experienced rather than inexperienced or trainee endoscopists, a prospective randomized trial was performed using only gastroenterologists with therapeutic endoscopy training. Consecutive patients undergoing elective outpatient colonoscopy were randomized to MIC or CC, with patients blinded to their group assignment. Endoscopic procedural metrics and quantities of conscious sedation medications were recorded during the procedures. The procedure was classified as “usual” or “difficult” by the endoscopist at the conclusion of each case based on the need for adjunctive maneuvers to facilitate endoscope advancement. After more than one hour post-procedure, patients completed a 10 cm visual analogue pain scale to reflect the degree of discomfort experienced during their colonoscopy. The primary outcome was patient comfort expressed by the visual analogue pain score. Secondary outcomes consisted of endoscopic procedural metrics as well as a sedation score derived from standardized dose increments of the conscious sedation medications.
RESULTS: Two hundred fifty-three patients were randomized and underwent MIC or CC between September 2011 and October 2012. The groups were similar in terms of the indications for colonoscopy and patient characteristics. There were no differences in cecal intubation rates (100% vs 99%), insertion distance-to-cecum (82 cm vs 83 cm), time-to-cecum (6.5 min vs 7.2 min), or polyp detection rate (47% vs 52%) between the MIC and CC groups. The primary outcome of mean pain score (1.0 vs 0.9 out of 10, P = 0.41) did not differ between MIC and CC groups, nor did the mean sedation score (8.2 vs 8.5, P = 0.34). Within the subgroup of cases considered more challenging or difficult, time-to-cecum was significantly faster with MIC compared to CC, 10.1 min vs 13.4 min respectively (P = 0.01). Sensitivity analyses confirmed a similar pattern of overall findings when each endoscopist was considered separately, demonstrating that the mean results for the entire group were not unduly influenced by outlier results from any one endoscopist.
CONCLUSION: Although the latest version of MIC resulted in faster times-to-cecum within a subgroup of more challenging cases, overall it was no better than CC in terms of patient comfort, sedation requirements and endoscopic procedural metrics, when performed in experienced hands.
doi:10.3748/wjg.v20.i36.13178
PMCID: PMC4177499  PMID: 25278714
Colonoscopy; Conscious sedation; Magnetic endoscope imaging; Pain measurement; Randomized controlled trial
7.  Cardiac safety in cluster headache patients using the very high dose of verapamil (≥720 mg/day) 
The Journal of Headache and Pain  2011;12(2):173-176.
Use of high doses of verapamil in preventive treatment of cluster headache (CH) is limited by cardiac toxicity. We systematically assess the cardiac safety of the very high dose of verapamil (verapamil VHD) in CH patients. Our work was a study performed in two French headache centers (Marseilles–Nice) from 12/2005 to 12/2008. CH patients treated with verapamil VHD (≥720 mg) were considered with a systematic electrocardiogram (EKG) monitoring. Among 200 CH patients, 29 (14.8%) used verapamil VHD (877 ± 227 mg/day). Incidence of EKG changes was 38% (11/29). Seven (24%) patients presented bradycardia considered as nonserious adverse event (NSAE) and four (14%) patients presented arrhythmia (heart block) considered as serious adverse event (SAE). Patients with EKG changes (1,003 ± 295 mg/day) were taking higher doses than those without EKG changes (800 ± 143 mg/day), but doses were similar in patients with SAE (990 ± 316 mg/day) and those with NSAE (1,011 ± 309 mg/day). Around three-quarters (8/11) of patients presented a delayed-onset cardiac adverse event (delay ≥2 years). Our work confirms the need for systematic EKG monitoring in CH patients treated with verapamil. Such cardiac safety assessment must be continued even for patients using VHD without any adverse event for a long time.
doi:10.1007/s10194-010-0289-x
PMCID: PMC3072493  PMID: 21258839
Cluster headache; Verapamil; Adverse events; EKG monitoring
8.  Cardiac safety in cluster headache patients using the very high dose of verapamil (≥720 mg/day) 
The Journal of Headache and Pain  2011;12(2):173-176.
Use of high doses of verapamil in preventive treatment of cluster headache (CH) is limited by cardiac toxicity. We systematically assess the cardiac safety of the very high dose of verapamil (verapamil VHD) in CH patients. Our work was a study performed in two French headache centers (Marseilles–Nice) from 12/2005 to 12/2008. CH patients treated with verapamil VHD (≥720 mg) were considered with a systematic electrocardiogram (EKG) monitoring. Among 200 CH patients, 29 (14.8%) used verapamil VHD (877 ± 227 mg/day). Incidence of EKG changes was 38% (11/29). Seven (24%) patients presented bradycardia considered as nonserious adverse event (NSAE) and four (14%) patients presented arrhythmia (heart block) considered as serious adverse event (SAE). Patients with EKG changes (1,003 ± 295 mg/day) were taking higher doses than those without EKG changes (800 ± 143 mg/day), but doses were similar in patients with SAE (990 ± 316 mg/day) and those with NSAE (1,011 ± 309 mg/day). Around three-quarters (8/11) of patients presented a delayed-onset cardiac adverse event (delay ≥2 years). Our work confirms the need for systematic EKG monitoring in CH patients treated with verapamil. Such cardiac safety assessment must be continued even for patients using VHD without any adverse event for a long time.
doi:10.1007/s10194-010-0289-x
PMCID: PMC3072493  PMID: 21258839
Cluster headache; Verapamil; Adverse events; EKG monitoring
9.  Effects of deep sedation or general anesthesia on cardiac function in mice undergoing cardiovascular magnetic resonance 
Background
Genetically engineered mouse models of human cardiovascular disease provide an opportunity to understand critical pathophysiological mechanisms. Cardiovascular magnetic resonance (CMR) provides precise reproducible assessment of cardiac structure and function, but, in contrast to echocardiography, requires that the animal be immobilized during image acquisition. General anesthetic regimens yield satisfactory images, but have the potential to significantly perturb cardiac function. The purpose of this study was to assess the effects of general anesthesia and a new deep sedation regimen, respectively, on cardiac function in mice as determined by CMR, and to compare them to results obtained in mildly sedated conscious mice by echocardiography.
Results
In 6 mildly sedated normal conscious mice assessed by echo, heart rate was 615 ± 25 min-1 (mean ± SE) and left ventricular ejection fraction (LVEF) was 0.94 ± 0.01. In the CMR studies of normal mice, heart rate was slightly lower during deep sedation with morphine/midazolam (583 ± 30 min-1), but the difference was not statistically significant. General anesthesia with 1% inhaled isoflurane significantly depressed heart rate (468 ± 7 min-1, p < 0.05 vs. conscious sedation). In 6 additional mice with ischemic LV failure, trends in heart rate were similar, but not statistically significant. In normal mice, deep sedation depressed LVEF (0.79 ± 0.04, p < 0.05 compared to light sedation), but to a significantly lesser extent than general anesthesia (0.60 ± 0.04, p < 0.05 vs. deep sedation).
In mice with ischemic LV failure, ejection fraction measurements were comparable when performed during light sedation, deep sedation, and general anesthesia, respectively. Contrast-to-noise ratios were similar during deep sedation and during general anesthesia, indicating comparable image quality. Left ventricular mass measurements made by CMR during deep sedation were nearly identical to those made during general anesthesia (r2 = 0.99, mean absolute difference < 4%), indicating equivalent quantitative accuracy obtained with the two methods. The imaging procedures were well-tolerated in all mice.
Conclusion
In mice with normal cardiac function, CMR during deep sedation causes significantly less depression of heart rate and ejection fraction than imaging during general anesthesia with isoflurane. In mice with heart failure, the sedation/anesthesia regimen had no clear impact on cardiac function. Deep sedation and general anesthesia produced CMR with comparable image quality and quantitative accuracy.
doi:10.1186/1532-429X-11-16
PMCID: PMC2689210  PMID: 19454023
10.  Sedation and Analgesia in Interventional Radiology 
ABSTRACT
Complex medical procedures requiring the administration of sedation and analgesia are frequently performed in sites outside the operating room. In particular, interventional radiologists must understand basic principles of sedation and analgesia to direct nurses or nurse practitioners to provide adequate conscious sedation. The purpose of this article is to review basic principles of sedation, pharmacologic agents used for sedation and analgesia, practice guidelines, monitoring, and management of common hemodynamic problems encountered during sedation.
doi:10.1055/s-2005-871866
PMCID: PMC3036269  PMID: 21326681
Sedation; analgesia; practice guidelines; nonanesthesiologist
11.  Bispectral EEG index monitoring of high-dose nitrous oxide and low-dose sevoflurane sedation. 
Anesthesia Progress  2002;49(2):56-62.
This single-blind controlled clinical study characterized the effects of 30-70% nitrous oxide (N2O) and 0.2-0.8% sevoflurane conscious sedation on quantitative electroencephalographic (EEG) readings of 22 healthy dental students as measured by the bispectral index (BIS). The study verified the 2 previously published BIS/N2O investigations showing no correlation between N2O dosage up to 70% and BIS. Observer's Assessment of Alertness and Sedation scores (OAA/S), however, correlated well with increasing doses of N2O from approximately 35 to 70%. A near linear dose-response relationship was established between OAA/S and end tidal (ET) sevoflurane concentrations of 0.4-0.7%. Only at the highest level of end tidal sevoflurane recorded, 0.7%, was statistically significant BIS depression seen. Subjects evaluated the acceptability of the sedative effect of the 2 gases, showing a slight preference for N2O. Comparable partial anterograde amnesia and sedation (OAA/S) were produced by both agents in administered concentrations of 40-70% N2O and 0.6-0.8% sevoflurane. Female subjects exhibited better memory and significantly less amnesia than males. No statistically significant changes occurred in any of the monitored vital signs. EMG readings demonstrated a statistically significant difference from control values only at the highest, 0.7%, ET concentration of sevoflurane. BIS does not appear useful for evaluating the level of nitrous oxide sedation in the dental setting but may have some value in assessing depth of sedation at deeper levels of sevoflurane sedation.
Images
PMCID: PMC2007394  PMID: 15384293
12.  A Randomized Double-Blind Pilot Study to Compare Conscious Sedation Produced by Diazepam Against Sufentanil 
Anesthesia Progress  1987;34(4):137-141.
Intravenous sufentanil, an analog of fentanyl, was compared to diazepam for conscious sedation in ambulatory dental outpatients. Ten patients undergoing the surgical removal of impacted third molars served as subjects in a double-blind, within-subject, single crossover study. Sedation was achieved with a combination of 30% nitrous oxide/70% oxygen by nasal mask and either diazepam (0.05—0.15 mg/kg) or sufentanic (0.05—0.15 μg/kg) titrated to a clinical endpoint of altered speech and relaxation. Intraoperative physiologic monitoring, patients' and the oral surgeon's subjective estimates of efficacy and psychomotor recovery were used to compare the two treatments. Both patients (eight of 10) and surgeons (six of 10) preferred sufentanil sedation. No significant differences were noted between treatments for psychomotor recovery. These preliminary data in a small sample suggest that sufentanil produces adequate conscious sedation in dental outpatients and should be evaluated further with larger patient samples.
PMCID: PMC2186288  PMID: 2964215
13.  Dental anesthetic management of a patient with ventricular arrhythmias. 
Anesthesia Progress  1998;45(2):68-73.
During routine deep sedation for endodontic therapy, a dentist-anesthesiologist observed premature ventricular contractions (PVCs) on a 62-yr-old woman's electrocardiogram (EKG) tracing. The dentist was able to complete the root canal procedure under intravenous (i.v.) sedation without any problems. The dentist-anesthesiologist referred the patient for medical evaluation. She was found to be free from ischemic cardiac disease with normal ventricular function. The patient was cleared to continue her dental treatment with deep sedation. She subsequently continued to undergo dental treatment with deep intravenous sedation without incident, although her EKG exhibited frequent PVCs, up to 20 per minute, including couplets and episodes of trigeminy. This article will review indications for medical intervention, antiarrhythmic medications, and anesthetic interventions for perioperative PVCs.
PMCID: PMC2148973  PMID: 10356435
14.  Clinical recovery time from conscious sedation for dental outpatients. 
Anesthesia Progress  2002;49(4):124-127.
For dental outpatients undergoing conscious sedation, recovery from sedation must be sufficient to allow safe discharge home, and many researchers have defined "recovery time" as the time until the patient was permitted to return home after the end of dental treatment. But it is frequently observed that patients remain in the clinic after receiving permission to go home. The present study investigated "clinical recovery time," which is defined as the time until discharge from the clinic after a dental procedure. We analyzed data from 61 outpatients who had received dental treatment under conscious sedation at the Hiroshima University Dental Hospital between January 1998 and December 2000 (nitrous oxide-oxygen inhalation sedation [n = 35], intravenous sedation with midazolam [n = 10], intravenous sedation with propofol [n = 16]). We found that the median clinical recovery time was 40 minutes after nitrous oxide-oxygen sedation, 80 minutes after midazolam sedation, and 52 minutes after propofol sedation. The clinical recovery time was about twice as long as the recovery time described in previous studies. In a comparison of the sedation methods, clinical recovery time differed (P = .0008), being longer in the midazolam sedation group than in the nitrous oxide-oxygen sedation group (P = .018). These results suggest the need for changes in treatment planning for dental outpatients undergoing conscious sedation.
PMCID: PMC2007416  PMID: 12779113
15.  Conscious Sedation and Emergency Department Length of Stay: A Comparison of Propofol, Ketamine, and Fentanyl/Versed 
Study Objectives:
Three of the most commonly used agents for conscious sedation in the Emergency Department (ED) are ketamine, fentanyl/versed, and propofol. In this study, we measured and compared the total times spent in the ED with each of these agents. Our objective was to determine whether the use of propofol for conscious sedation was associated with a shorter length of ED stay as compared to the other two agents.
Methods:
This was a consecutive case series. All patients who required procedural conscious sedation who presented to the ED at University of California, Irvine Medical Center from January 2003 through April 2004 were included in the study. The attending ED physician evaluated the patient and determined which medication(s) would be administered. All patients underwent procedural sedation according to the ED’s standardized sedation protocol. The times and dosages of administered medications and the sedation/consciousness level (SCL) scores were recorded by ED nurses at 3–5 minute intervals. Data was abstracted prospectively. The time to sedation (first dose of agent to SCL score of 2 or less) and time to recovery (last dose of agent to SCL score of 4) of the different regimens were then analyzed and compared.
Results:
Thirty-eight patients received propofol, 38 received ketamine, and 14 received fentanyl/versed. The mean times to sedation (minutes) were: propofol 4.5 (95% CI: 3.3–5.7), ketamine 10.6 (95% CI: 5.8–15.4), fentanyl/versed 11.5 (95% CI: 3.5–19.4). The mean times to recovery were: propofol 21.6 (95% CI: 16.1–27.1), ketamine 55.4 (95% CI: 46.2–64.5), fentanyl/versed 59.9 (95% CI: 20.3–99.5). Propofol had a statistically significant shorter time to sedation than both ketamine (p<.001) and fentanyl/versed (p=.022). Propofol also produced shorter recovery times than both ketamine (p<.001) and fentanyl/versed (p=.002).
Conclusion:
In this study, sedation and recovery times were shorter with propofol than with ketamine or fentanyl/versed. The use of propofol for conscious sedation in this non-randomized study was associated with a shorter ED length of stay.
PMCID: PMC2872520  PMID: 20505814
16.  A risk management audit: are we complying with the national guidelines for sedation by non-anaesthetists? 
OBJECTIVES: To assess the effect of a preprinted form in ensuring an improved and sustained quality of documentation of clinical data in compliance with the national guidelines for sedation by non-anaesthetists. DESIGN: The process of retrospective case note audit was used to identify areas of poor performance, reiterate national guidelines, introduce a post-sedation advice sheet, and demonstrate improvement. SETTING: Emergency Department, Musgrove Park Hospital, Taunton. SUBJECTS: Forty seven patients requiring sedation for relocation of a dislocated shoulder or manipulation of a Colles' fracture between July and October 1996 and July and October 1997. MAIN OUTCOME MEASURES: Evidence that the following items had been documented: consent for procedure, risk assessment, monitored observations, prophylactic use of supplementary oxygen, and discharging patients with printed advice. Case note review was performed before (n = 23) and after (n = 24) the introduction of a sedation audit form. Notes were analysed for the above outcome measures. The monitored observations analysed included: pulse oximetry, respiratory rate, pulse rate, blood pressure, electrocardiography, and conscious level. RESULTS: Use of the form significantly improved documentation of most parameters measured. CONCLUSIONS: Introduction of the form, together with staff education, resulted in enhanced documentation of data and improved conformity with national guidelines. A risk management approach to preempting critical incidents following sedation, can be adopted in this area of emergency medicine.
PMCID: PMC1343296  PMID: 10191447
17.  Bravo (wireless) ambulatory esophageal pH monitoring: How do day 1 and day 2 results compare? 
AIM: To investigate if differences exist for patients’ gastroesophageal reflux as measured by the Bravo ambulatory esophageal pH system between d 1 and d 2.
METHODS: A retrospective study of 27 consecutive adult patients who underwent Bravo esophageal pH monitoring was performed. Patients underwent EGD under IV conscious sedation prior to Bravo placement. Acid reflux variables and symptom scores for d 1 were compared to d 2.
RESULTS: The mean doses of fentanyl and midazolam were 90.4 μg and 7.2 mg, respectively. D 1 results were significantly more elevated than d 2 with respect to total time pH < 4, upright position reflux, and mean number of long refluxes. No statistical difference was noted between the two days for supine position reflux, number of refluxes, duration of longest reflux, episodes of heartburn, and symptom score.
CONCLUSION: Patients undergoing Bravo esophageal pH monitoring in association with EGD and moderate conscious sedation experience significantly more acid reflux on d 1 compared to d 2. The IV sedation may be responsible for the increased reflux on d 1. Performed this way, 48-h Bravo results may not be entirely representative of the patients’ true GE reflux profile.
doi:10.3748/wjg.v13.i30.4091
PMCID: PMC4205310  PMID: 17696227
Esophageal pH monitoring; Bravo; Gastroeso-phageal reflux disease; Reflux; pH testing
18.  Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial 
Trials  2013;14:92.
Background
A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the ‘conscious target’: patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs.
Methods/Design
A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses.
Discussion
This ‘educational research’ project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake.
Trial registration number
Clinicaltrials.gov #NCT01360346
doi:10.1186/1745-6215-14-92
PMCID: PMC3651718  PMID: 23551983
Sedation; Hydroxyzine; Melatonin; Enteral approach; High-risk critically ill; Educational research
19.  Dexmedetomidine ameliorates monitored anaesthesia care 
Indian Journal of Anaesthesia  2014;58(2):154-159.
Background and Aims:
Monitored anaesthesia care (MAC) is meant for procedures under local anaesthesia. Various drugs have been used for this purpose. The recently introduced alpha2 agonist, dexmedetomidine provides “conscious sedation” with adequate analgesia and minimal respiratory depression. Hence, the safety and efficacy of two doses of dexmedetomidine for sedation and analgesia were evaluated.
Methods:
A total of 90 patients were distributed in three groups of 30 each: Dexmedetomidine 0.5 μg/kg (DL), dexmedetomidine 1.0 μg/kg (DH) and normal saline (C). The initial loading dose was followed by maintenance infusion of 0.2-0.7 μg/kg/h of dexmedetomidine or equivalent volume of saline. Study drug was started at least 15 min before placement of local anaesthesia. Drugs were titrated to a target level of sedation (=3 on Ramsay sedation scale [RSS]). Midazolam 0.02 mg/kg for RSS < 3 and fentanyl 0.5 μg/kg were supplemented as required. The statistical analysis was performed using Chi-square test and mean and anova analysis.
Results:
In groups DL and DH fewer patients required supplemental midazolam, 56.7% (17/30) and 40% (12/30), compared with control, where 86.7% (26/30)needed midazolam supplements. P = 0.000. Both groups DL and DH required significantly less fentanyl (84.8 and 83.9 μg) versus control (144.2 μg). There was significantly increased ease of achieving and maintaining targeted sedation and analgesia in both dexmedetomidine groups when compared with placebo (P = 0.001). Adverse events observed with dexmedetomidine were bradycardia and hypotension.
Conclusions:
Dexmedetomidine in the doses studied was considered safe and effective sedative and analgesic for patients undergoing procedures under MAC.
doi:10.4103/0019-5049.130816
PMCID: PMC4050931  PMID: 24963179
Conscious sedation; dexmedetomidine; monitored anaesthesia care; respiratory depression
20.  Prognostic factors for death and survival with or without complications in cardiac arrest patients receiving CPR within 24 hours of anesthesia for emergency surgery 
Purpose
To determine prognostic factors for death and survival with or without complications in cardiac arrest patients who received cardiopulmonary resuscitation (CPR) within 24 hours of receiving anesthesia for emergency surgery.
Patients and methods
A retrospective cohort study approved by the Maharaj Nakorn Chiang Mai University Hospital Ethical Committee. Data used were taken from records of 751 cardiac arrest patients who received their first CPR within 24 hours of anesthesia for emergency surgery between January 1, 2003 and October 31, 2011. The reviewed data included patient characteristics, surgical procedures, American Society of Anesthesiologist (ASA) physical status classification, anesthesia information, the timing of cardiac arrest, CPR details, and outcomes at 24 hours after CPR. Univariate and polytomous logistic regression analyses were used to determine prognostic factors associated with the outcome variable. P-values of less than 0.05 were considered statistically significant.
Results
The outcomes at 24 hours were death (638/751, 85.0%), survival with complications (73/751, 9.7%), and survival without complications (40/751, 5.3%). The prognostic factors associated with death were: age between 13–34 years (OR =3.08, 95% CI =1.03–9.19); ASA physical status three and higher (OR =6.60, 95% CI =2.17–20.13); precardiopulmonary comorbidity (OR =3.28, 95% CI =1.09–9.90); the condition of patients who were on mechanical ventilation prior to receiving anesthesia (OR =4.11, 95% CI =1.17–14.38); surgery in the upper abdominal site (OR =14.64, 95% CI =2.83–75.82); shock prior to cardiac arrest (OR =6.24, 95% CI =2.53–15.36); nonshockable electrocardiography (EKG) rhythm (OR =5.67, 95% CI =1.93–16.62); cardiac arrest occurring in postoperative period (OR =7.35, 95% CI =2.89–18.74); and duration of CPR more than 30 minutes (OR =4.32, 95% CI =1.39–13.45). The prognostic factors associated with survival with complications were being greater than or equal to 65 years of age (OR =4.30, 95% CI =1.13–16.42), upper abdominal site of surgery (OR =10.86, 95% CI =1.99–59.13), shock prior to cardiac arrest (OR =3.62, 95% CI =1.30–10.12), arrhythmia prior to cardiac arrest (OR =4.61, 95% CI =1.01–21.13), and cardiac arrest occurring in the postoperative period (OR =3.63, 95% CI =1.31–10.02).
Conclusion
The mortality and morbidity in patients who received anesthesia for emergency surgery within 24 hours of their first CPR were high, and were associated with identifiable patient comorbidity, age, shock, anatomic site of operation, the timing of cardiac arrest, EKG rhythm, and the duration of CPR. EKG monitoring helps to identify cardiac arrest quickly and diagnose the EKG rhythm as a shockable or nonshockable rhythm, with CPR being performed as per the American Heart Association (AHA) CPR Guidelines 2010. The use of the fast track system in combination with an interdisciplinary team for surgery, CPR, and postoperative care helps to rescue patients in a short time.
doi:10.2147/RMHP.S68797
PMCID: PMC4218906  PMID: 25378961
CPR; cardiac arrest; emergency surgery; prognostic factors; death; survival; survival with complications; mortality; morbidity
21.  Identification of Factors that Influence Conscious Sedation in Gastrointestinal Endoscopy 
Journal of Korean Medical Science  2009;19(4):536-540.
Although several studies examined factors that influence conscious sedation, investigation was limited into the gender and age. The aim of this prospective study is to identify the clinical variables of successful conscious sedation during gastrointestinal endoscopy. A total of 300 subjects who underwent gastrointestinal endoscopy were enrolled in a prospective fashion. They completed a questionnaire to assess height, weight, drinking, smoking, education level, recent medication, past medical history, previous experience of conscious sedation, preprocedural anxiety, and apprehension about the procedure. Efficacy of sedation and amnesia were evaluated by the subject and the endoscopist. Amnesic and sedative effects were proportionally related with age (p<0.0001). Preprocedural anxiety level was higher in women (p=0.0062), younger subjects (p=0.035), slender subjects (p=0.041), and in those without previous experience of conscious sedation (p=0.0034). This anxiety level was also related to increased pain (p=0.0026) and alertness (p=0.0003) during the procedure. Lower dose of midazolam is needed for sedation in older subjects. Subjects with a high level of preprocedural anxiety such as women, younger subjects, slender subjects, and those without previous experience of conscious sedation should be sedated with great caution because generally, they complain of much more severe pain and alertness during the procedure.
doi:10.3346/jkms.2004.19.4.536
PMCID: PMC2816887  PMID: 15308844
Amnesia; Conscious Sedation; Endoscopy, Gastrointestinal; Midazolam
22.  Safe Sedation and Hypnosis using Dexmedetomidine for Minimally Invasive Spine Surgery in a Prone Position 
The Korean Journal of Pain  2014;27(4):313-320.
Dexmedetomidine, an imidazoline compound, is a highly selective α2-adrenoceptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. In order to minimize the patients' pain and anxiety during minimally invasive spine surgery (MISS) when compared to conventional surgery under general anesthesia, an adequate conscious sedation (CS) or monitored anesthetic care (MAC) should be provided. Commonly used intravenous sedatives and hypnotics, such as midazolam and propofol, are not suitable for operations in a prone position due to undesired respiratory depression. Dexmedetomidine converges on an endogenous non-rapid eye movement (NREM) sleep-promoting pathway to exert its sedative effects. The great merit of dexmedetomidine for CS or MAC is the ability of the operator to recognize nerve damage during percutaneous endoscopic lumbar discectomy, a representative MISS. However, there are 2 shortcomings for dexmedetomidine in MISS: hypotension/bradycardia and delayed emergence. Its hypotension/bradycardiac effects can be prevented by ketamine intraoperatively. Using atipamezole (an α2-adrenoceptor antagonist) might allow doctors to control the rate of recovery from procedural sedation in the future. MAC, with other analgesics such as ketorolac and opioids, creates ideal conditions for MISS. In conclusion, dexmedetomidine provides a favorable surgical condition in patients receiving MISS in a prone position due to its unique properties of conscious sedation followed by unconscious hypnosis with analgesia. However, no respiratory depression occurs based on the dexmedetomidine-related endogenous sleep pathways involves the inhibition of the locus coeruleus in the pons, which facilitates VLPO firing in the anterior hypothalamus.
doi:10.3344/kjp.2014.27.4.313
PMCID: PMC4196495  PMID: 25317279
adrenergic alpha-2 receptor agonists; conscious sedation; dexmedetomidine; minimally invasive surgical procedures; percutaneous discectomy
23.  An Alternative Approach to the Monitoring of Respiration by Dynamic Air-Pressure Sensor 
Anesthesia Progress  2007;54(1):2-6.
Monitoring and assessing of patient respiratory function during conscious sedation are important because many drugs used for conscious sedation produce respiratory depression and subsequent hypoventilation. The purpose of this study is to assess the value of a dynamic air-pressure sensor for respiratory monitoring of clothed patients. Eight clothed adult volunteers were reclined on a dental chair positioned horizontally. The air bag for measuring air-pressure signals corresponding to respiration was placed on the seat back of the dental chair in the central lumbar area of the subject. The subject breathed through a face mask with a respirometer attached for measuring expiratory tidal volume. The air-pressure signals corresponding to respiration were obtained and the time integration values for air pressure during each expiration (∫Pexp) were calculated. The expiratory tidal volume (TVexp) was measured simultaneously by respirometer. The relationship between TVexp and ∫Pexp for each subject was assessed by a Pearson correlation coefficient. A strong correlation between TVexp and ∫Pexp was observed in all subjects. Measuring ∫Pexp by dynamic air-pressure sensor makes it possible to estimate respiratory volume breath by breath, and the respiratory pressure–time integral waveform was useful in visually monitoring the respiration pattern. We believe that in the future this device will be used to monitor respiratory physiology in clothed patients, contributing to safer sedative procedures.
doi:10.2344/0003-3006(2007)54[2:AAATTM]2.0.CO;2
PMCID: PMC1821134  PMID: 17352526
Air-pressure sensor; Respiratory; Monitor; Nonrestrictively
24.  Preoperative anxiety and propofol requirement in conscious sedation for ovum retrieval. 
Journal of Korean Medical Science  2003;18(6):863-868.
The purpose of the present study was to evaluate the correlation among the trial number of in vitro fertilization (IVF), preoperative anxiety, and propofol requirement for conscious sedation. One hundred and twenty six Korean women undergoing oocyte retrieval were enrolled. The target-controlled infusion by the anesthesiologist was conducted with initial target propofol concentration of 2.5 microg/mL, which was manipulated until the sedation score 3 and desired clinical end point were achieved. A weak correlation was observed between visual analogue scale (VAS) anxiety and the dose of propofol required for the induction of conscious sedation (r=0.22, p=0.0192). A weak correlation was also found between VAS anxiety and the sedation time needed to reach the proper conscious sedation level for the procedure (r=0.181, p=0.0484). Multiple regression analysis showed that VAS anxiety, preoperative baseline prolactin level, and cortisol level had statistically significant effects on the propofol induction dose for target controlled conscious sedation. We concluded that the induction dose and time requirements for propofol in anesthesiologist-controlled conscious sedation be modified based on the preoperative anxiety level and the baseline blood concentration of stress hormone, cortisol and prolactin.
PMCID: PMC3055125  PMID: 14676445
25.  A prospective study on pain score with transperineal prostatic gold seed fiducial implantation under local anesthetic alone 
Background:
The purpose of this study was to monitor patient pain score with transperineal prostatic gold seed implantation in the absence of conscious sedation.
Methods:
All patients who were scheduled for image-guided external beam radiation (IGRT) and referred for gold seed fiducials were eligible to participate. Gold seed implants were performed by two radiation oncologists between December 2007 and April 2008. Patients received only local and deep anesthetic. No patients had prophylactic IV cannulation for the procedure. Three gold seeds were inserted transperineally into the prostate. A visual analogue scale from 0 to 10 was used to assess the pain at baseline, local and deep anesthetic infiltration, with each seed drop, and after the completion of the procedure.
Results:
A total of 30 patients were accrued to this study. The highest recorded increase in pain score was at the time point of deep local anesthesia, at which the mean pain score was 3.8. The mean pain scores at each seed drop were 0.8 (standard deviation [SD]=1.24), 1 (SD=1.26), and 0.5 (SD=0.90), respectively. All gold seed insertion procedures were well-tolerated, with no patients having significant pain post-procedure, and no significant procedural complications. There were only slight increases in dysuria, urinary frequency, constipation, urinary retention and flatulence in 7 patients – none of which required intervention.
Interpretation:
Transperineal ultrasound-guided gold seed implantation without conscious sedation is well-tolerated and associated with a low complication rate. It is a convenient outpatient procedure obviating the need for resource intensive postoperative monitoring.
doi:10.5489/cuaj.11225
PMCID: PMC3650768  PMID: 23671528

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