Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial.
ABSTRACT: Although endoscopic submucosal dissection (ESD) is routinely performed under sedation, the difference in ESD performance according to sedation method is not well known. This study attempted to prospectively assess and compare the satisfaction of the endoscopists and patient stability during ESD between two sedation methods.One hundred and fifty-four adult patients scheduled for ESD were sedated by either the IMIE (intermittent midazolam/propofol injection by endoscopist) or CPIA (continuous propofol infusion by anesthesiologist) method. The primary endpoint of this study was to compare the level of satisfaction of the endoscopists between the two groups. The secondary endpoints included level of satisfaction of the patients, patient's pain scores, events interfering with the procedure, incidence of unintended deep sedation, hemodynamic and respiratory events, and ESD outcomes and complications.Level of satisfaction of the endoscopists was significantly higher in the CPIA Group compared to the IMIE group (IMIE vs. CPIA; high satisfaction score; 63.2% vs. 87.2%, P=0.001). The incidence of unintended deep sedation was significantly higher in the IMIE Group compared to the CPIA Group (IMIE vs. CPIA; 17.1% vs. 5.1%, P=0.018) as well as the number of patients showing spontaneous movement or those requiring physical restraint (IMIE vs. CPIA; spontaneous movement; 60.5% vs. 42.3%, P=0.024, physical restraint; 27.6% vs. 10.3%, P=0.006, respectively). In contrast, level of satisfaction of the patients were found to be significantly higher in the IMIE Group (IMIE vs. CPIA; high satisfaction score; 85.5% vs. 67.9%, P=0.027). Pain scores of the patients, hemodynamic and respiratory events, and ESD outcomes and complications were not different between the two groups.Continuous propofol and remifentanil infusion by an anesthesiologist during ESD can increase the satisfaction levels of the endoscopists by providing a more stable state of sedation.ClinicalTrials.gov NCT01806753.
Project description:To compare the efficacy and safety of sedation protocols for endoscopic submucosal dissection (ESD) between dexmedetomidine-remifentanil and propofol-remifentanil.Fifty-nine patients scheduled for ESD were randomly allocated into a dexmedetomidine-remifentanil (DR) group or a propofol-remifentanil (PR) group. To control patient anxiety, dexmedetomidine or propofol was infused to maintain a score of 4-5 on the Modified Observer's Assessment of Alertness/Sedation scale. Remifentanil was infused continuously at a rate of 6 ?g/kg per hour in both groups. The ease of advancing the scope into the throat, gastric motility grading, and satisfaction of the endoscopist and patient were assessed. Hemodynamic variables and hypoxemic events were compared to evaluate patient safety.Demographic data were comparable between the groups. The hemodynamic variables and pulse oximetry values were stable during the procedure in both groups despite a lower heart rate in the DR group. No oxygen desaturation events occurred in either group. Although advancing the scope into the throat was easier in the PR group ("very easy" 24.1% vs 56.7%, P = 0.010), gastric motility was more suppressed in the DR group ("no + mild" 96.6% vs 73.3%, P = 0.013). The endoscopists felt that the procedure was more favorable in the DR group ("very good + good" 100% vs 86.7%, P = 0.042), whereas patient satisfaction scores were comparable between the groups. En bloc resection was performed 100% of the time in both groups, and the complete resection rate was 94.4% in the DR group and 100% in the PR group (P = 0.477).The efficacy and safety of dexmedetomidine and remifentanil were comparable to propofol and remifentanil during ESD. However, the endoscopists favored dexmedetomidine perhaps due to lower gastric motility.
Project description:Endoscopic submucosal dissection (ESD) is a technically difficult and lengthy procedure requiring optimal depth of sedation. The bispectral index (BIS) monitor is a non-invasive tool that objectively evaluates the depth of sedation. The purpose of this prospective randomized controlled trial was to evaluate whether BIS guided sedation with propofol and remifentanil could reduce the number of patients requiring rescue propofol, and thus reduce the incidence of sedation- and/or procedure-related complications.A total of 180 patients who underwent the ESD procedure for gastric adenoma or early gastric cancer were randomized to two groups. The control group (n=90) was monitored by the Modified Observer's Assessment of Alertness and Sedation scale and the BIS group (n=90) was monitored using BIS. The total doses of propofol and remifentanil, the need for rescue propofol, and the rates of complications were recorded.The number of patients who needed rescue propofol during the procedure was significantly higher in the control group than the BIS group (47.8% vs. 30.0%, p=0.014). There were no significant differences in the incidence of sedation- and/or procedure-related complications.BIS-guided propofol infusion combined with remifentanil reduced the number of patients requiring rescue propofol in ESD procedures. However, this finding did not lead to clinical benefits and thus BIS monitoring is of limited use during anesthesiologist-directed sedation.
Project description:The importance of providing effective analgesia during sedation for complex endoscopic procedures has been widely recognized. However, repeated administration of opioids in order to achieve sufficient analgesia may carry the risk of delayed recovery after propofol based sedation. This study was done to compare recovery profiles and the satisfaction of the endoscopists and patients between conventional balanced propofol sedation and analgesia-oriented combination sedation for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).Two hundred and two adult patients scheduled for ERCP were sedated by either the Conventional (initial bolus of meperidine with propofol infusion) or Combination (repeated bolus doses of fentanyl with propofol infusion) method. Recovery profiles, satisfaction levels of the endoscopists and patients, drug requirements and complications were compared between groups.Patients of the Combination Group required significantly less propofol compared to the Conventional Group (135.0 ± 68.8 mg vs. 165.3 ± 81.7 mg, P = 0.005). Modified Aldrete scores were not different between groups throughout the recovery period, and recovery times were also comparable between groups. Satisfaction scores were not different between the two groups in both the endoscopists and patients (P = 0.868 and 0.890, respectively).Considering the significant reduction in propofol dose, the non-inferiority of recovery profiles and satisfaction scores of the endoscopists and patients, analgesia oriented combination sedation may be a more safe yet effective sedative method compared to conventional balanced propofol sedation during ERCP.
Project description:Endoscopic submucosal dissection (ESD) is an advanced therapy for early gastric neoplasm and requires sedation with adequate analgesia. Lidocaine is a short-acting local anesthetic, and intravenous lidocaine has been shown to have analgesic efficacy in surgical settings. The aim of this study was to assess the effects of intravenous lidocaine on analgesic and sedative requirements for ESD and pain after ESD.Sixty-six patients scheduled for ESD randomly received either intravenous lidocaine as a bolus of 1.5?mg/kg before sedation, followed by continuous infusion at a rate of 2?mg/kg/h during sedation (lidocaine group; n?=?33) or the same bolus and infusion volumes of normal saline (control group; n?=?33). Sedation was achieved with propofol and fentanyl. The primary outcome was fentanyl requirement during ESD. We recorded hemodynamics and any events during ESD and evaluated post-ESD epigastric and throat pain.Fentanyl requirement during ESD reduced by 24% in the lidocaine group compared with the control group (105?±?28 vs. 138?±?37??g, mean?±?SD; P?<?0.001). The lidocaine group reached sedation faster [40 (20-100) vs. 55 (30-120) s, median (range); P?=?0.001], and incidence of patient movement during ESD decreased in the lidocaine group (3% vs. 26%, P?=?0.026). Numerical rating scale for epigastric pain was significantly lower at 6?hours after ESD [2 (0-6) vs. 3 (0-8), median (range); P?=?0.023] and incidence of throat pain was significantly lower in the lidocaine group (27% vs. 65%, P?=?0.003). No adverse events associated with lidocaine were discovered.Administration of intravenous lidocaine reduced fentanyl requirement and decreased patient movement during ESD. Moreover, it alleviated epigastric and throat pain after ESD. Thus, we conclude that the use of intravenous adjuvant lidocaine is a new and safe sedative method during ESD.
Project description:BACKGROUND:Immersive virtual reality (IVR) is a form of distraction therapy that has shown potential as an analgesia and sedation sparing agent. This study assessed the effect of IVR on the self-administered sedation requirements of patients undergoing joint replacement surgery under regional anesthesia in a single center. METHODS AND FINDINGS:This study was a single-center, randomized control trial at St Vincent's Hospital in Melbourne, Australia. Fifty patients undergoing elective total knee and total hip arthroplasty were randomized to IVR and Propofol patient-controlled sedation (PCS) or propofol PCS alone. The primary outcome measure was intra-operative propofol use. Secondary outcomes included pattern of propofol use over time, use of adjunct analgesia, unmet propofol demand, and patient satisfaction survey scores. Of 50 total patients, 25 received IVR in conjunction with PCS, and 25 received PCS alone. All patients received adjunct analgesia from the treating Anesthesiologist. Median propofol use/hour over the entire procedure in the control group was 40 (11.1, 93.9) mg/hour compared with 45 (0, 94.7) mg/hour in the IVR group (p = 0.90). There were no differences in patterns of propofol use over the course of each procedure. Adjusting for various baseline characteristics did not change the results. Postoperative satisfaction scores were equivalent in both groups. The VR intervention was well tolerated by all patients, with no report of major side effects. Key limitations were relatively small sample size, the non-blinded nature of the study, and use of adjunct analgesia. CONCLUSIONS:In patients receiving joint replacement surgery under regional anesthesia with PCS, IVR was well tolerated but did not decrease the overall sedation requirement.
Project description:Endoscopic submucosal dissection (ESD) is routinely performed in treating gastric neoplasia and requires long-term higher levels of sedation. Endoscopist-directed nurse-administered sedation (EDNAS) has not been well studied in ESD. This study aimed to evaluate the safety and effectiveness of EDNAS for ESD.Patients treated with ESD for gastric tumors between 2013 and 2015 were retrospectively collected. Patients were divided into a midazolam-treated group (M group) and a midazolam plus propofol-treated group (MP group). Clinical outcome, safety, effectiveness, adverse events of ESD, and adverse events of sedation were analyzed.Of 209 collected patients, 83 were in the M group and 126 were in the MP group. Of all patients, 67 patients had the circulatory adverse event during the ESD procedure. Sedation method was the only significant risk factor (M versus MP: 2.17 (1.14-4.15), p = 0.019). In analysis of MP subgroups, 47 patients suffered an adverse event from sedation, and current smoking was the only significant association factor for adverse event (0.15 (0.03-0.68), p = 0.014).In performing ESD, the effect of sedation is reduced in smoking patients. EDNAS may be acceptable for ESD under careful monitoring of vital sign and oxygen saturation.
Project description:AIM:To determine whether topical lidocaine benefits esophagogastroduoduenoscopy (EGD) by decreasing propofol dose necessary for sedation or procedure-related complications. METHODS:The study was designed as a prospective, single centre, double blind, randomised clinical trial and was conducted in 2012 between January and May (NCT01489891). Consecutive patients undergoing EGD were randomly assigned to receive supplemental topical lidocaine (L; 50 mg in an excipient solution which was applied as a spray to the oropharynx) or placebo (P; taste excipients solution without active substance, similarly delivered) prior to the standard propofol sedation procedure. The propofol was administered as a bolus intravenous (iv) dose, with patients in the L and P groups receiving initial doses based on the patient's American Society of Anaesthesiologists (ASA) classification (ASA?I-II: 0.50-0.60 mg/kg; ASA III-IV: 0.25-0.35 mg/kg), followed by 10-20 mg iv dose every 30-60 s at the anaesthetist's discretion. Vital signs, anthropometric measurements, amount of propofol administered, sedation level reached, examination time, and the subjective assessments of the endoscopist's and anaesthetist's satisfaction (based upon a four point Likert scale) were recorded. All statistical tests were performed by the Stata statistical software suite (Release 11, 2009; StataCorp, LP, College Station, TX, United States). RESULTS:No significant differences were found between the groups treated with lidocaine or placebo in terms of total propofol dose (310.7 ± 139.2 mg/kg per minute vs 280.1 ± 87.7 mg/kg per minute, P = 0.15) or intraprocedural propofol dose (135.3 ± 151.7 mg/kg per minute vs 122.7 ± 96.5 mg/kg per minute, P = 0.58). Only when the L and P groups were analysed with the particular subgroups of female, < 65-year-old, and lower anaesthetic risk level (ASA?I-II) was a statistically significant difference found (L: 336.5 ± 141.2 mg/kg per minute vs P: 284.6 ± 91.2 mg/kg per minute, P = 0.03) for greater total propofol requirements). The total incidence of complications was also similar between the two groups, with the L group showing a complication rate of 32.2% (95%CI: 21.6-45.0) and the P group showing a complication rate of 26.7% (95%CI: 17.0-39.0). In addition, the use of lidocaine had no effect on the anaesthetist's or endoscopist's satisfaction with the procedure. Thus, the endoscopist's satisfaction Likert assessments were equally distributed among the L and P groups: unsatisfactory, [L: 6.8% (95%CI: 2.2-15.5) vs P: 0% (95%CI: 0-4.8); neutral, L: 10.1% (95%CI: 4.2-19.9) vs P: 15% (95%CI: 7.6-25.7)]; satisfactory, [L: 25.4% (95%CI: 10-29.6) vs P: 18.3% (95%CI: 15.5-37.6); and very satisfactory, L: 57.6% (95%CI: 54-77.7) vs P: 66.6% (95%CI: 44.8-69.7)]. Likewise, the anaesthetist's satisfaction Likert assessments regarding the ease of maintaining a patient at an optimum sedation level without agitation or modification of the projected sedation protocol were not affected by the application of lidocaine, as evidenced by the lack of significant differences between the scores for the placebo group: unsatisfactory, L: 5.8% (95%CI: 1.3-13.2) vs P: 0% (95%CI: 0-4.8); neutral, L: 16.9% (95%CI: 8.9-28.4) vs P: 16.7% (95%CI: 8.8-27.7); satisfactory, L: 15.2% (95%CI: 7.7-26.1) vs P: 20.3% (95%CI: 11.3-31.6); and very satisfactory, L: 62.7% (95%CI: 49.9-74.3) vs P: 63.3% (95%CI: 50.6-74.7). CONCLUSION:Topical pharyngeal anaesthesia is safe in EGD but does not reduce the necessary dose of propofol or improve the anaesthetist's or endoscopist's satisfaction with the procedure.
Project description:Conscious sedation for colorectal endoscopic submucosal dissection (ESD) has not been standardized, and there are no studies of sedation for colorectal ESD.We conducted a prospective double-blind randomized controlled trial to clarify the usefulness of DEX during colorectal ESD. In total 80 patients with colorectal ESD from April 2016 to May 2017 were assigned to the placebo group or the DEX group (40 cases each). The primary outcome was patient satisfaction (visual analogue scale: VAS). Secondary outcomes were evaluated for 13 factors, including patient pain level (VAS), endoscopist satisfaction (VAS), objective patient pain level viewed from the endoscopist's perspective (VAS), rate of patient response, rate of side effects, etc., from the patient's and endoscopist's perspectives.Patient satisfaction was 8.4 and 9.1 (P?=?0.018) in the placebo group and the DEX group, respectively. Secondary outcomes of patient pain level, endoscopist satisfaction, objective patient pain level from the endoscopist's perspective for the placebo and DEX groups were 1.2 and 0.4 (P?=?0.045), 8.2 and 9.3 (P?<?0.001), and 1.2 and 0.5 (P?=?0.002), respectively. All of these were significantly positive results (more comfortable and less pain) in the DEX group. The rate of a patient response was 100% in all cases. The side effects (hypoxia/bradycardia/hypotension) were 0%/0%/0% and 7.5%/7.5%/5% (P?=?0.030). However, these rates were less than the reported side effect occurrence rate, and no additional medication was needed.DEX enables conscious sedation, and is useful not only for patient and endoscopist satisfaction but also for pain relief. DEX is an effective sedation method for colorectal ESD.
Project description:Objectives:To examine the impact of endoscopy setting (hospital-based vs. office-based) on sedation/analgesia administration and to provide nationwide data on monitoring practices among Greek gastroenterologists in real-world settings. Material and Methods. A web-based survey regarding sedation/analgesia rates and monitoring practices during endoscopy either in a hospital-based or in an office-based setting was disseminated to the members of the Hellenic Society of Gastroenterology and Professional Association of Gastroenterologists. Participants were asked to complete a questionnaire, which consisted of 35 items, stratified into 4 sections: demographics, preprocedure (informed consent, initial patient evaluation), intraprocedure (monitoring practices, sedative agents' administration rate), and postprocedure practices (recovery). Results:211 individuals responded (response rate: 40.3%). Propofol use was significantly higher in the private hospital compared to the public hospital and the office-based setting for esophagogastroduodenoscopy (EGD) (85.8% vs. 19.5% vs. 10.5%, p < 0.0001) and colonoscopy (88.2% vs. 20.1% vs. 9.4%, p < 0.0001). This effect was not detected for midazolam, pethidine, and fentanyl use. Endoscopists themselves administered the medications in most cases. However, a significant contribution of anesthesiology sedation/analgesia provision was detected in private hospitals (14.7% vs. 2.8% vs. 2.4%, p < 0.001) compared to the other settings. Only 35.2% of the private offices have a separate recovery room, compared to 80.4% and 58.7% of the private hospital- and public hospital-based facilities, respectively, while the nursing personnel monitored patients' recovery in most of the cases. Participants were familiar with airway management techniques (83.9% with bag valve mask and 23.2% with endotracheal intubation), while 49.7% and 21.8% had received Basic Life Support (BLS) and Advanced Life Support (ALS) training, respectively. Conclusion:The private hospital-based setting is associated with higher propofol sedation administration both for EGD and for colonoscopy. Greek endoscopists are adequately trained in airway management techniques.
Project description: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.