Propofol sedation during gastrointestinal endoscopy arouses euphoria in a large subset of patients.

BACKGROUND: Propofol is recommended for sedation in gastrointestinal endoscopy (GE), but preliminary data suggest addictive potentials. OBJECTIVE: The objective of this article is to evaluate the frequency of predominantly euphoric reaction after GE and patients' subsequent reminiscences. METHODS: Eighty-two patients undergoing elective GE under propofol sedation were enrolled in a prospective observational study. The grade of anxiety, expectation or relief about the examination's result and affective state in terms of cheerfulness, relaxation, activation, sedation and anxiety were surveyed using a numeric rating scale (1 to 10) immediately before (t1), after GE (t2) and seven days (t3) later. Statistics: hierarchical cluster analysis, heat map, χ2 test and paired t test. RESULTS: Mean propofol dosage was 264 ± 120 mg. Two clusters of mood changes emerged (t1 vs. t2). One (n = 46, 56.1%) was characterized by an unease reaction pattern with equal values regarding cheerfulness, relaxation and anxiety, while relaxation decreased; the other cluster showed a euphoric reaction pattern (n = 36, 43.9%) with markedly increased cheerfulness, relaxation and decreased anxiety. These effects intensified at recall (t3). Despite similar endoscopy results, euphoric cluster patients rated these more positively. CONCLUSION: Propofol induces euphoria in nearly half of the patients undergoing elective GE with persisting, even enhanced reminiscence (germanctr.de, trial number DRKS00011202).

Women awaken faster than men after electroencephalogram-monitored propofol sedation for colonoscopy: A prospective observational study.

BACKGROUND: Sedation for colonoscopy using intravenous propofol has become standard in many Western countries. OBJECTIVE: Gender-specific differences have been shown for general anaesthesia in dentistry, but no such data existed for gastrointestinal endoscopy. DESIGN: A prospective observational study. SETTING: An academic teaching hospital of Hannover Medical School. PATIENTS: A total of 219 patients (108 women and 111 men) scheduled for colonoscopy. INTERVENTION: Propofol sedation using electroencephalogram monitoring during a constant level of sedation depth (D0 to D2) performed by trained nurses or physicians after a body-weight-adjusted loading dose. MAIN OUTCOME MEASURES: The primary end-point was the presence of gender-specific differences in awakening time (time from end of sedation to eye-opening and complete orientation); secondary outcome parameters analysed were total dose of propofol, sedation-associated complications (bradycardia, hypotension, hypoxaemia and apnoea), patient cooperation and patient satisfaction. Multivariate analysis was performed to correct confounding factors such as age and BMI. RESULTS: Women awakened significantly faster than men, with a time to eye-opening of 7.3 ±â€Š3.7 versus 8.4 ±â€Š3.4 min (P = 0.005) and time until complete orientation of 9.1 ±â€Š3.9 versus 10.4 ±â€Š13.7 min (P = 0.008). The propofol dosage was not significantly different, with some trend towards more propofol per kg body weight in women (3.98 ±â€Š1.81 mg versus 3.72 ±â€Š1.75 mg, P = 0.232). CONCLUSION: The effect of gender aspects should be considered when propofol is used as sedation for gastrointestinal endoscopy. That includes adequate dosing for women as well as caution regarding potential overdosing of male patients. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT02687568).

Clinical value of the Integrated Pulmonary Index® during sedation for interventional upper GI-endoscopy: A randomized, prospective tri-center study.

BACKGROUND AND STUDY AIMS: The Integrated Pulmonary Index® (IPI) is a mathematically-determined factor based on parameters of capnography and pulse oximetry, which should enable sensitive detection of impaired respiratory function. Aim was to investigate whether an additional measurement of the IPI during sedation for interventional endoscopy, compared to standard monitoring alone, allows a reduction of sedation-related respiratory depression. PATIENTS AND METHODS: 170 patients with standard monitoring randomly underwent either a blinded recording of capnography (control group, n=87) or capnography, including automated IPI calculation (IPI group, n=83), during deep sedation with midazolam and propofol. The primary endpoint was the maximum decrease of oxygen saturation from the baseline level before sedation. Secondary endpoints: incidence of hypoxemia (SaO2<90%), other sedation-related complications (apnea rate, bradycardia, hypotension), patient cooperation and satisfaction (VAS). RESULTS: Mean propofol dose in the IPI group (245±61mg) was comparable to the control group (225±47mg). The average drop of the oxygen saturation in the IPI group (6.5±4.1%) was nearly identical to that of the control group (7.1±4.6%, p=0.44). Apnea episodes >15s was found in 46 patients of the control and 31 of the IPI group (p<0.05). Frequency of occurrence of a drop in pO2-saturation <90%, bradycardia <50/min or a drop of systolic pressure <90mmHg were not significantly different in both groups. Mechanical ventilation was not required in any case. Patient cooperation and satisfaction were assessed similar in both groups. CONCLUSION: A clinically appealing advantage of IPI-assessment during deep sedation with midazolam and propofol for interventional endoscopy could not be documented. However, IPI registration was more effective in reducing the incidence of apnea episodes.

Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study).

BACKGROUND AND STUDY AIMS: This was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxemia during midazolam and propofol sedation for endoscopic retrograde cholangiopancreatography (ERCP). METHODS: Patients (American Society of Anesthesiologists [ASA] I ­â€ŠIV) scheduled for ERCP under midazolam and propofol sedation were randomly assigned to a control arm with standard monitoring or an interventional arm with additional capnographic monitoring. In both arms detection of apnea prompted withholding of propofol administration, stimulation of the patient, insertion of a nasopharyngeal tube, or further measures. The primary study end point was incidence of hypoxemia (oxygen saturation [Sao 2] below 90 %); secondary end points included occurrences of severe hypoxemia (Sao 2 ≤ 85 %), bradycardia, and hypotension, and sedation quality (patient cooperation and satisfaction). RESULTS: 242 patients were enrolled at three German endoscopy centers. Intention-to-treat analysis revealed no significant reduction in hypoxemia incidence in the capnography arm compared with the standard arm (38.0 % vs. 44.4 %, P = 0.314). Apnea was more frequently detected in the capnography arm (64.5 % vs. 6.0 %, P < 0.001). There were no differences regarding rates of bradycardia and hypotension. Per-protocol analysis showed lower incidence of hypoxemia in the capnography arm compared with the standard arm (31.5 % vs. 44.8 %, P = 0.048). There was one death related to sedation in the standard arm. Sedation quality was similar in the two groups. CONCLUSION: Intention-to-treat analysis showed hypoxemia incidence was not significantly lower in the additional capnography arm compared with standard monitoring. Additional capnographic monitoring of ventilatory activity resulted in improved detection of apnea.

Safety and efficacy of a newly developed baby-sphincterotome for cannulation and precut in cases of failed selective wire-guided bile duct access: a prospective 8-year clinical evaluation.

BACKGROUND: Precut sphincterotomy (PCS) is a well-established alternative after repeated unsuccessful attempts of common bile duct (CBD) cannulation using standard catheters and/or guide-wire. Commonly used instruments for precutting are the needle-knife and a modified traction-type sphincterotome. In 1996, a so-called 'baby-sphincterotome' with a preshaped, small-caliber 3 Fr tip was developed, which enables cannulation and precutting in one step. OBJECTIVE: A clinical evaluation was carried out and the complication rates were determined at a tertiary referral hospital. DESIGN: Prospective clinical evaluation. INTERVENTIONS: During an 8-year period, a total of 5389 endoscopic retrograde cholangiopancreatographies were performed at our hospital. In total, 1886 patients fulfilled the inclusion criteria for this prospective study. The baby-sphincterotome was used in 345 of 1886 patients (mean age 63.4 ± 16.4 years, 203 women) after five unsuccessful attempts of CBD cannulation using a hydrophilic guide-wire. After two more failed CBD cannulations with the baby-sphincterotome, PCS was performed using the same device. MAIN OUTCOME MEASUREMENTS: The success rates of biliary access, postendoscopic retrograde cholangiopancreatography pancreatitis, and bleeding were assessed. RESULTS: Initially, the success rate of CBD cannulation on using the baby-sphincterotome was 28% (96/345 patients). Postinterventional pancreatitis occurred in two of 96 patients (2%) and minor bleeding occurred during traction-type sphincterotomy in four of 93 patients (4%). In the remaining 249 patients precut with a baby-sphincterotome, CBD cannulation was achieved in 219 cases (88%), although with pancreatitis and severe bleeding in 4% each. In 30 of 249 patients (12%), a second or a third (n=5) intervention was necessary, with a success rate of 73% (22/30 cases) after PCS. LIMITATIONS: This was a single-centre, uncontrolled study. CONCLUSION: The newly developed baby-sphincterotome enables bile duct access in a single session in 91% of the patients when guide-wire cannulation has failed. Direct cannulation was possible in about one-quarter of the patients, whereas PCS with the new device showed a high efficacy and a low complication rate.

Capnographic monitoring reduces the incidence of arterial oxygen desaturation and hypoxemia during propofol sedation for colonoscopy: a randomized, controlled study (ColoCap Study).

OBJECTIVES: The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of arterial oxygen desaturation during propofol sedation for colonoscopy. METHODS: Patients (American Society of Anesthesiologists classification (ASA) 1-3) scheduled for colonoscopy under propofol sedation were randomly assigned to either a control arm with standard monitoring (standard arm) or an interventional arm in which additional capnographic monitoring (capnography arm) was available. In both study arms, detection of apnea or altered respiration induced withholding propofol administration, stimulation of the patient, chin lift maneuver, or further measures. The primary study end point was the incidence of arterial oxygen desaturation (defined as a fall in oxygen saturation (SaO(2)) of ≥5% or <90%); secondary end points included the occurrences of hypoxemia (SaO(2) <90%), severe hypoxemia (SaO(2) ≤85%), bradycardia, hypotension, and the quality of sedation (patient cooperation and patient satisfaction). RESULTS: A total of 760 patients were enrolled at three German endoscopy centers. The intention-to-treat analysis revealed a significant reduction of the incidence of oxygen desaturation in the capnography arm in comparison with the standard arm (38.9% vs. 53.2%; P<0.001). The numbers of patients with a fall in SaO(2) <90% and ≤85% were also significantly different (12.5% vs. 19.8%; P=0.008 and 3.7 vs. 7.8%; P=0.018). There were no differences regarding the rates of bradycardia and hypotension. Quality of sedation was similar in both groups. Results of statistical analyses were maintained for the per-protocol population. CONCLUSIONS: Additional capnographic monitoring of ventilatory activity reduces the incidence of oxygen desaturation and hypoxemia during propofol sedation for colonoscopy.

Intermittent manually controlled versus continuous infusion of propofol for deep sedation during interventional endoscopy: a prospective randomized trial.

INTRODUCTION: Beside the traditional, intermittent bolus application of propofol, continuous propofol infusion via infusion pump is an alternative procedure for deep sedation during long-lasting interventional endoscopy. However, up to now, there are no randomized comparisons for gastrointestinal endoscopy. METHODS: One hundred patients (ERCP: n = 60, EUS: n = 40) were randomly assigned to receive intermittent bolus application ("bolus group") or continuous infusion ("perfusor group") of propofol sedation after induction with 3 mg midazolam for deep sedation. Patients in the bolus group received an initial propofol dose according to body weight (bw <70 kg: 40 mg; bw ≥ 70 kg 60 mg). In the perfusor group, bw-adapted, continuous propofol infusion (6 mg/kg) via the Injectomat 2000 MC (Fresenius-Kabi) was administered after an initial bolus of 1 mg/kg. Vital signs, dose of propofol, patient cooperation (VAS 1-10), sedation depth, and the recovery time as well as the quality of recovery were evaluated. RESULTS: Total propofol dose in the bolus group 305 ± 155 mg (100-570 mg) and in the perfusor group 343 ± 123 mg (126-590 mg, p = 0.5) were comparable. Oxygen saturation below 90% was seen in four patients of each group, with no need for assisted ventilation. Arterial blood pressure <90 mmHg was documented in two patients in the bolus group and seven patients in the perfusor group (p = 0.16). Patients' cooperation was rated as good in both groups (bolus group, 9.1 ± 0.9; perfusor group, 8.9 ± 1; p = 0.17). Recovery time was significantly shorter in the bolus group compared with the perfusor group (19 ± 5 versus 23 ± 6 min, p < 0.001) whereas the quality of recovery was nearly identical in both groups. CONCLUSION: Both sedation regimens allow nearly identical good controllability of propofol sedation. However, recovery time was significantly slower and hypotension was tended to occur more often in the perfusor group.

Propofol, the preferred sedation for screening colonoscopy, is underused. Results of an international survey.

BACKGROUND: The use of propofol during colonoscopy has become more widespread. To increase availability while maintaining quality and decreasing costs, European Guidelines have been issued for non-anesthesiologist administration of propofol (NAAP). We aimed to assess the current use of propofol during screening colonoscopy. METHODS: International survey. RESULTS: Eighty-four questionnaires were collected from endoscopists practicing in 29 countries. Practices were most often located in high-volume community hospitals (Italy, Belgium, Spain, Netherlands in half cases). An anesthesiologist was regularly present in the Endoscopy Unit of 69.0% survey respondents. In low-risk (ASA classification, 1-2) patients, propofol, benzodiazepine+opioids and benzodiazepine alone were used in 45%, 31% and 14% of screening colonoscopies, respectively. Propofol was associated with the highest endoscopist satisfaction (score on a 10-point visual analogue scale, 9.2±1.2 vs. 5.5±1.9 and 4.7±2.0 for benzodiazepine+opioids and benzodiazepine alone, respectively; P<0.0001). NAAP was used by 29.9% of respondents in 9 countries and approximately two-thirds of other endoscopists would consider implementing NAAP. Main reasons for not considering NAAP implementation were medico-legal issues and cost. CONCLUSION: Propofol provides the highest endoscopist satisfaction but it is used in less than half of screening colonoscopies. Propofol is administered by non-anesthesiologists in one-third of settings; its implementation is foreseen by a majority of endoscopists who do not currently use it.