Safety of applying midazolam-ketamine-propofol sedation combination under the supervision of endoscopy nurse with patient-controlled analgesia pump in colonoscopy.
ABSTRACT: AIM:To compare the results of midazolam-ketamine-propofol sedation performed by an endoscopy nurse and anaesthetist during colonoscopy in terms of patient satisfaction and safety. METHODS:American Statistical Association (ASA) I-II 60 patients who underwent colonoscopy under sedation were randomly divided into two groups: sedation under the supervision of an anaesthetist (SSA) and sedation under the supervision of an endoscopy nurse (SSEN). Both groups were initially administered 1 mg midazolam, 50 mg ketamine and 30-50 mg propofol. Continuation of sedation was performed by the anaesthetist in the SSA group and the nurse with a patient-controlled analgesia (PCA) pump in the SSEN group. The total propofol consumption, procedure duration, recovery times, pain using the visual analogue scale (VAS) and satisfaction score of the patients, and side effects were recorded. In addition, the patients were asked whether they remembered the procedure and whether they would prefer the same method in the case of re-endoscopy. RESULTS:Total propofol consumption in the SSEN group was significantly higher (P < 0.05) than that in the SSA group. When the groups were compared in terms of VAS score, recovery time, patient satisfaction, recall of the procedure, re-preference for the same method in case of re-endoscopy, and side effects, there were no significant differences (P > 0.05) between the two groups. No long-term required intervention side effects were observed in either group. CONCLUSION:Colonoscopy sedation in ASA I-II patients can be safely performed by an endoscopy nurse using PCA pump with the incidence of side effects and patient satisfaction levels similar to sedation under anaesthetist supervision.
Project description:BACKGROUND:The clinical efficacy of effect-site targeted patient-maintained propofol sedation (PMPS) compared to anaesthetist-controlled propofol sedation (ACPS) for patients undergoing awake joint replacement surgery is currently unknown. There is no commercially available medical device capable of delivering PMPS so we have designed and built such a device. We plan a clinical trial to compare PMPS to ACPS and to collect data relating to the safety of our prototype device in delivering sedation. METHODS:The trial is an open-label, randomised, controlled superiority trial recruiting adults who are undergoing elective primary lower-limb arthroplasty with sedation by propofol infusion by effect-site targeting into two equal-sized parallel arms: PMPS and ACPS. The primary research objective is to compare the body-weight-normalised rate of propofol consumption when sedation for surgery on adults undergoing elective primary lower-limb arthroplasty under spinal anaesthesia is patient-maintained versus when it is anaesthetist-controlled. The study primary null hypothesis is that there is no difference in the rate of propofol consumption when sedation is patient-maintained versus anaesthetist-controlled. DISCUSSION:This is the first trial to test the superiority of effect-site-targeted patient-maintained propofol sedation versus anaesthetist-controlled propofol sedation in terms of total propofol consumption during the sedation period. The results of this trial will help inform clinicians and device manufacturers of the clinical efficacy and safety of patient-maintained propofol sedation applied to a common operative setting. TRIAL REGISTRATION:International Standard Randomised Controlled Trial Number Registry, ISRCTN29129799 . Prospectively registered on 12 June 2018.
Project description:BACKGROUND: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. METHODS: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. RESULTS: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. CONCLUSION: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.
Project description:BACKGROUND:Propofol sedation is effective for gastrointestinal endoscopic procedures, but its narrow therapeutic window highlights the importance of identifying an optimal administration technique regarding effectiveness and safety. This study aimed to determine the incidence of significant adverse events in adult patients scheduled for gastrointestinal endoscopy under anaesthetist-performed sedation using propofol target-controlled infusion and determine the existence of associations between these events and potentially related variables. METHODS:This single-centre, retrospective cohort study took place in a tertiary referral university hospital. Medical records of 823 patients (age?>?18?years, American Society of Anesthesiologists physical status classification scores I-III) who had undergone elective gastrointestinal endoscopy under propofol target-controlled infusion sedation during September 2018 were reviewed. Outcomes included hypoxia, hypotension, and bradycardia events, requirement of vasoactive drugs, unplanned tracheal intubation or supraglottic device insertion, and need for advanced cardiac life support. RESULTS:The most frequently encountered adverse event was oxygen desaturation <?95% with an incidence of 22.35%. Vasoactive drug administration, hypotension, and oxygen desaturation <?90% followed, with incidences of 19.2, 12.64, and 9.92%, respectively. Only 0.5% of patients required advanced airway management. Multivariate analysis revealed an association between hypotension events, colonoscopic procedures, and propofol doses (odds ratio: 3.08, 95% confidence interval: 1.43 to 6.61; P?=?0.004 and odds ratio: 1.14, 95% confidence interval: 1.00 to 1.29; P?=?0.046). A strong dose-effect relationship was found between hypoxia and obesity; patients with body mass index ?40 were nine times (odds ratio: 10.22, 95% confidence interval: 2.83 to 36.99) more likely to experience oxygen desaturation <?90% events. CONCLUSIONS:Propofol sedation using target-controlled infusion appears to be a safe and effective anaesthetic technique for gastrointestinal endoscopic procedures with acceptable rates of adverse events and could be more widely adopted in clinical practice.
Project description:To assess the efficacy and safety of propofol sedation for gastrointestinal endoscopy, we conducted a meta-analysis of randomized controlled trials (RCTs) comparing propofol with traditional sedative agents.RCTs comparing the effects of propofol and traditional sedative agents during gastrointestinal endoscopy were found on MEDLINE, the Cochrane Central Register of Controlled Trials, and EMBASE. Cardiopulmonary complications (i.e., hypoxia, hypotension, arrhythmia, and apnea) and sedation profiles were assessed.Twenty-two original RCTs investigating a total of 1,798 patients, of whom 912 received propofol only and 886 received traditional sedative agents only, met the inclusion criteria. Propofol use was associated with shorter recovery (13 studies, 1,165 patients; WMD -19.75; 95% CI -27.65, 11.86) and discharge times (seven studies, 471 patients; WMD -29.48; 95% CI -44.13, -14.83), higher post-anesthesia recovery scores (four studies, 503 patients; WMD 2.03; 95% CI 1.59, 2.46), better sedation (nine studies, 592 patients; OR 4.78; 95% CI 2.56, 8.93), and greater patient cooperation (six studies, 709 patients; WMD 1.27; 95% CI 0.53, 2.02), as well as more local pain on injection (six studies, 547 patients; OR 10.19; 95% CI 3.93, 26.39). Effects of propofol on cardiopulmonary complications, procedure duration, amnesia, pain during endoscopy, and patient satisfaction were not found to be significantly different from those of traditional sedative agents.Propofol is safe and effective for gastrointestinal endoscopy procedures and is associated with shorter recovery and discharge periods, higher post-anesthesia recovery scores, better sedation, and greater patient cooperation than traditional sedation, without an increase in cardiopulmonary complications. Care should be taken when extrapolating our results to specific practice settings and high-risk patient subgroups.
Project description:Background and Aims:Same day bidirectional endoscopies (esophagogastroduodenoscopies [EGD]s and colonoscopies) are routinely performed. However, the best sequence of procedures is unknown, as is whether the use of carbon dioxide (CO2) affects the preferred sequence of procedures. This study aims to determine the preferred sequence of procedures and choice of insufflation gas (air or CO2) in patients undergoing same day bidirectional endoscopies. Methods:Two hundred adults with a clinical indication for same day bidirectional endoscopies were randomized equally into four groups: A1 (EGD first, CO2 as insufflator); A2 (EGD first, air as insufflator); B1 (colonoscopy first, CO2 as insufflator); and B2 (colonoscopy first, air as insufflator). All procedures were performed with conscious sedation (Midazolam/Fentanyl). The primary outcome was patients' overall comfort/satisfaction with the procedures and sedation received, as assessed by questionnaires and validated scoring scales (Nurse-Assessed Patient Comfort Score [NAPCOMS], La Crosse [WI]) collected during the procedures, before discharge, and on day 7 postprocedure. Results:Two hundred patients were randomized, with data available for 186. Mean Midazolam dose between groups was significantly less in the EGD first groups (P=0.01). During the procedures, no differences were found in patients' comfort as per the nurse reported NAPCOMS scores (P=0.19) or the Lacrosse (WI) endoscopy scores (P=0.05). On postprocedure days 0 and 7, no differences were found in the patients' reported Lacrosse (WI) scores, nausea, sore throat, dizziness, satisfaction with sedation or overall level of procedural satisfaction (P>0.05 for each). However, bloating and discomfort were significantly lower in the CO2 arms (P<0.001). Conclusions:This randomized controlled trial using validated patient comfort scoring assessments for same day bidirectional endoscopies demonstrated that the sequence of procedures affects the sedation used but does not affect overall patient comfort or satisfaction. Lesser sedation is needed in the EGD first group, and less postprocedural abdominal pain/discomfort and bloating is seen with CO2 insufflation.
Project description:Gastrointestinal endoscopy can be difficult for patients to tolerate. Studies on endoscopic tolerability mainly focus on gastroscopy or colonoscopy with a paucity of data on double balloon enteroscopy (DBE). We aimed to prospectively evaluate tolerability in patients undergoing several forms of endoscopy including DBE.Consecutive patients undergoing colonoscopy, flexible sigmoidoscopy, gastroscopy, endoscopic retrograde pancreatography (ERCP), capsule endoscopy (CE) and DBE were prospectively recruited. A questionnaire recorded demographics, procedural data, patient tolerability (pain, discomfort and distress recorded on numerical rating scales) and the Hospital Anxiety and Depression Scale (HADS).956 patients were recruited (512 women; median age 57?years). The median pain score for DBE was poor with a score of 5 compared with 1 and 0 for oesophagogastroduodenoscopy and ERCP, respectively (p<0.001). Colonoscopy and retrograde DBE scores were not dissimilar. CE was well tolerated with a median pain score of 0. Patients with DBE required significantly higher doses of sedation and analgesia than other patients. The HADS Anxiety Score was also associated with poorer tolerability.DBE is poorly tolerated when compared with other forms of endoscopy despite higher doses of sedation. Increasing demand to improve tolerability of DBE in the UK may be addressed with the use of propofol.
Project description:BACKGROUND/AIMS:It is unclear whether patients with irritable bowel syndrome (IBS) require a high dose of sedatives during colonoscopy. In this study, we investigated the pre-procedural anxiety levels, sedative consumption, procedure times, complications, and patient's satisfaction between patients with IBS and controls for ambulatory colonoscopy under sedation. MATERIALS AND METHODS:Rome III criteria were used in the diagnosis of IBS. Anxiety levels were measured using Spielberger's State-Trait Anxiety Inventory (STAI) and Beck Anxiety Inventory (BAI). Patients received a fixed dose of midazolam (0.02 mg/kg), fentanyl (1 ?g/kg), ketamine (0.3 mg/kg), and incremental doses of propofol under sedation protocol. Demographic data, heart rate, blood pressure, and oxygen saturation were measured. Procedure times, recovery and discharge times, drug doses used, complications associated with the sedation, and patient's satisfaction scores were also recorded. RESULTS:The mean Trait (p=0.015), State (p=0.029), Beck anxiety scores (p=0.018), the incidence of disruptive movements (p=0.044), and the amount of propofol (p=0. 024) used were significantly higher in patients with IBS. There was a decline in mean systolic blood pressure at the 6th minute in patients with IBS (p=0.026). No association was found between the sedative requirement and the anxiety scores. CONCLUSION:Patients with IBS who underwent elective colonoscopy procedures expressed higher pre-procedural anxiety scores, required more propofol consumption, and experienced more disruptive movements compared with controls. On the contrary, the increased propofol consumption was not associated with the increased pre-procedural anxiety scores.
Project description:Gastrointestinal endoscopies are invasive and unpleasant procedures that are increasingly being used worldwide. The importance of high quality procedures (especially in colorectal cancer screening), the increasing patient awareness and the expectation of painless examination, increase the need for procedural sedation. The best single sedation agent for endoscopy is propofol which, due to its' pharmacokinetic/dynamic profile allows for a higher patient satisfaction and procedural quality and lower induction and recovery times, while maintaining the safety of traditional sedation. Propofol is an anesthetic agent when used in higher doses than those needed for endoscopy. Because of this important feature it may lead to cardiovascular and respiratory depression and, ultimately, to cardiac arrest and death. Fueled by this argument, concern over the safety of its administration by personnel without general anesthesia training has arisen. Propofol usage seems to be increasing but it's still underused. It is a safe alternative for simple endoscopic procedures in low risk patients even if administered by non-anesthesiologists. Evidence on propofol safety in complex procedures and high risk patients is less robust and in these cases, the presence of an anesthetist should be considered. We review the existing evidence on the topic and evaluate the regional differences on sedation practices.
Project description:<h4>Background</h4>Sedation is commonly used in gastrointestinal endoscopy; however, considerable variability in sedation practices has been reported. The objective of this review was to identify and synthesize existing recommendations on sedation practices for routine gastrointestinal endoscopy procedures.<h4>Methods</h4>We systematically reviewed guidelines and position statements identified through a search of PubMed, guidelines databases, and websites of relevant professional associations from January 1, 2005 to May 10, 2019. We included English-language guidelines/position statements with recommendations relating to sedation for adults undergoing routine gastrointestinal endoscopy. Documents with guidance only for complex endoscopic procedures were excluded. We extracted and synthesized recommendations relating to: 1) choice of sedatives, 2) sedation administration, 3) personnel responsible for monitoring sedated patients, 4) skills and training of individuals involved in sedation, and 5) equipment required for monitoring sedated patients. We assessed the quality of included documents using the Appraisal of Guidelines for Research & Evaluation (AGREE) II tool.<h4>Results</h4>We identified 19 guidelines and 7 position statements meeting inclusion criteria. Documents generally agreed that a single, trained registered nurse can administer moderate sedation, monitor the patient, and assist with brief, interruptible tasks. Documents also agreed on the routine use of pulse oximetry and blood pressure monitoring during endoscopy. However, recommendations relating to the drugs to be used for sedation, the healthcare personnel capable of administering propofol and monitoring patients sedated with propofol, and the need for capnography when monitoring sedated patients varied. Only 9 documents provided a grade or level of evidence in support of their recommendations.<h4>Conclusions</h4>Recommendations for sedation practices in routine gastrointestinal endoscopy differ across guidelines/position statements and often lack supporting evidence with potential implications for patient safety and procedural efficiency.
Project description:Endoscopist-Directed Nurse-Administered Propofol Sedation (EDNAPS) has been evaluated in community settings rather than tertiary referral centers.A hospital-wide prospectively collected database of Medical Emergency Team Calls (METCALL), emergency responses triggered by medically unstable patients, was reviewed. Responses that followed EDNAPS were extracted and compared with a prospectively entered database of all endoscopies performed using EDNAPS over the same period.A total of 33,539 endoscopic procedures (16,393 gastroscopies, 17,146 colonoscopies) were performed on 27,989 patients using EDNAPS. Intravenous drugs included midazolam (0 - 5 mg), fentanyl (0 - 100 mcg), and propofol (10 - 420 mg). Of 23 METCALLs (18 gastroscopies and 5 colonoscopies), there were 16 with ASA scores of III or higher. Indications for gastroscopy were gastrointestinal (GI) hemorrhage (n = 11; 8 variceal, 3 nonvariceal), dysphagia (n = 5), PEG removal (n = 1), and dyspepsia (n = 1). Fifteen of 22 patients, including all of those who had a colonoscopy, made a full recovery and returned to the ward or were discharged home. In the gastroscopy group, seven were intubated and admitted to Intensive Care, of whom six were emergency cases for gastrointestinal bleeding (n = 4 variceal, n = 2 non variceal) and one in which the indication was PEG removal. Two deaths occurred in the intubated group.In a tertiary referral center, EDNAPS for low-to-moderate risk (ASA ≤ 2) patients undergoing gastroscopy and colonoscopy is very safe. Gastroscopy is associated with greater anesthetic risk than colonoscopy and those with high ASA scores needing urgent endoscopy for upper gastrointestinal hemorrhage are at particular risk of cardiorespiratory decompensation.