Safety and tolerability outcomes of nonanesthesiologist-administered propofol using target-controlled infusion in routine GI endoscopy.

BACKGROUND AND AIMS: Nonanesthesiologist-administered propofol (NAAP) is increasingly accepted, but data are limited on drug administration using target-controlled infusion (TCI) in clinical practice. TCI adjusts the drug infusion based on patient-specific parameters, maintaining a constant drug dose to reduce the risk of adverse events (AEs) because of drug overdosing and to enhance patient comfort. The aims of this study were to assess the rate of AEs and to evaluate patient satisfaction with NAAP using TCI in a retrospective cohort of 18,302 procedures. METHODS: Low-risk patients (American Society of Anesthesiologists score I and II) undergoing outpatient GI endoscopic procedures, including EGDs and colonoscopies, were sequentially enrolled at IRCCS San Raffaele Hospital (Milan, Italy) between May 2019 and November 2021. RESULTS: Data from 7162 EGDs and 11,140 colonoscopies were analyzed. Mean patient age was 59.1 ± 14.8 years, and mean body mass index was 24.9 ± 3.7 kg/m2. The male-to-female ratio was equal at 8798 (48.1%):9486 (51.9%). AEs occurred in 240 procedures (1.3%) out of the total cohort, with no differences between EGDs and colonoscopies (100 [1.4%] and 140 [1.2%], respectively; P = .418). Most patients (15,875 [98.9%]) indicated they would likely repeat the procedure with the same sedation protocol. Age (odds ratio, 1.02; 95% confidence interval, 1.01-1.03; P < .008) was the only independent factor associated with overall AEs. CONCLUSIONS: NAAP using TCI is an effective and safe sedation method for routine endoscopy. The proper propofol dosage based on individual patients and the presence of trained operators are crucial for NAAP sedation management.

Risk of adverse events in gastrointestinal endoscopy: Zero-inflated Poisson regression mixture model for count data and multinomial logit model for the type of event.

BACKGROUND AND AIMS: We analyze the possible predictive variables for Adverse Events (AEs) during sedation for gastrointestinal (GI) endoscopy. METHODS: We consider 23,788 GI endoscopies under sedation on adults between 2012 and 2019. A Zero-Inflated Poisson Regression Mixture (ZIPRM) model for count data with concomitant variables is applied, accounting for unobserved heterogeneity and evaluating the risks of multi-drug sedation. A multinomial logit model is also estimated to evaluate cardiovascular, respiratory, hemorrhagic, other AEs and stopping the procedure risk factors. RESULTS: In 7.55% of cases, one or more AEs occurred, most frequently cardiovascular (3.26%) or respiratory (2.77%). Our ZIPRM model identifies one population for non-zero counts. The AE-group reveals that age >75 years yields 46% more AEs than age <66 years; Body Mass Index (BMI) ≥27 27% more AEs than BMI <21; emergency 11% more AEs than routine. Any one-point increment in the American Society of Anesthesiologists (ASA) score and the Mallampati score determines respectively a 42% and a 16% increment in AEs; every hour prolonging endoscopy increases AEs by 41%. Regarding sedation with propofol alone (the sedative of choice), adding opioids to propofol increases AEs by 43% and adding benzodiazepines by 51%. Cardiovascular AEs are increased by age, ASA score, smoke, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. Respiratory AEs are increased by BMI, ASA and Mallampati scores, emergency, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. Hemorrhagic AEs are increased by age, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. The risk of suspension of the endoscopic procedure before accomplishment is increased by female gender, ASA and Mallampati scores, and in-hospital, and it is reduced by emergency and procedure duration. CONCLUSIONS: Age, BMI, ASA score, Mallampati score, in-hospital, procedure duration, other sedatives with propofol increase the risk for AEs during sedation for GI endoscopy.

Two Different Endoscopic Procedures Made Feasible by the Janus Mask in a High-Risk Patient.

The Janus mask is a full face mask designed for providing noninvasive ventilation (NIV) during any kind of upper endoscopies (e.g., fiber-optic bronchoscopy, gastrointestinal endoscopy, and transesophageal echocardiography). Due to its unique conformation, its use can be considered for both elective and urgent endoscopic procedures in high-risk patients. In this case report, we present a patient with acute respiratory failure who underwent two consecutive different endoscopic procedures (fiber-optic bronchoscopy and gastrointestinal endoscopy) during continuous positive airway pressure support by means of this novel NIV mask, thus avoiding tracheal intubation and at the same time, improving his respiratory condition.

Swallowing Impairment During Propofol Target-Controlled Infusion.

BACKGROUND: Sedatives can impair the swallowing process. We assessed the incidence and severity of swallowing impairment in patients sedated with propofol at clinically relevant doses. We also identified factors that were predictive of swallowing impairment. METHODS: In 80 patients scheduled to undergo elective gastrointestinal endoscopy under target-controlled infusion (TCI) propofol sedation, swallowing was evaluated by glottis videoendoscopy, using the Dysphagia Severity Score (DSS) and the Penetration and Aspiration Scale (PAS). The level of sedation was assessed with the Observer's Assessment of Alertness/Sedation (OAAS) scale. Evaluations were obtained within each patient at 3 target effect-site propofol concentrations of 2, 3, and 4 µg/mL (Marsh model). RESULTS: At 2 µg/mL TCI, the OAAS score was 2 in 21 (26.25%) patients and 1 in 59 (73.75%). The OAAS score was 1 in all patients at 3 and 4 µg/mL TCI target. At 3 µg/mL TCI target, 19 (24.36%) patients had a DSS = 3 and 18 patients (23.08%) had a PAS = 7-8 (severe swallowing impairment). DSS was associated with increasing age (5-year odds ratio [OR] 1.53 [1.22-1.93]; P < 0.001), body mass index (BMI; OR 1.24 [1.08-1.42]; P = 0.002), and TCI target (OR 15.80 [7.76-32.20]; P < 0.001). In an alternative model incorporating OAAS instead of TCI target, DSS was associated with increasing age (5-year OR 1.13 [1.02-1.24]; P = 0.014) and BMI (OR 1.08 [1.02-1.15]; P = 0.006) and decreasing OAAS (OR 0.05 [0.006-0.36]; P = 0.003). PAS was associated with increasing age (5-year OR 1.09 [1.04-1.15]; P < 0.001), BMI (OR 1.23 [1.07-1.41]; P = 0.003), and TCI target (OR 15.23 [7.45-31.16]; P < 0.001). In an alternative model incorporating OAAS instead of TCI target, PAS was associated with increasing age (5-year OR 1.14 [1.04-1.26]; P = 0.007) and BMI (OR 1.09 [1.02-1.15]; P = 0.006) and decreasing OAAS (OR 0.05 [0.006-0.41]; P = 0.005). CONCLUSIONS: Aspiration due to swallowing impairment may occur during deep sedation produced by propofol at commonly used TCI targets. TCI targets are predictors of swallowing impairment; increased age and high BMI are concomitant risk factors.

Target Controlled Infusion for non-anaesthesiologist propofol sedation during gastrointestinal endoscopy: The first double blind randomized controlled trial.

BACKGROUND: Target Controlled Infusion is a sophisticated tool for providing optimal sedation regimen avoiding under or oversedation in gastrointestinal endoscopy. AIMS: To compare standard moderate sedation vs. non-anaesthesiologist-administered propofol sedation during gastrointestinal endoscopy. METHODS: Randomized controlled trial of 70 consecutive colonoscopies and 70 consecutive esophagogastroduodenoscopies (EGD). Standard group (n=70), received fentanyl (1 µg/kg)+midazolam (0.03-0.04 mg/kg) or midazolam only; propofol group (n=70), received fentanyl (1 µg/kg)+propofol Target Controlled Infusion (1.2-1.6 µg/ml) or propofol Target Controlled Infusion only. Discharge time, endoscopist satisfaction and patient satisfaction were recorded in all endoscopies. RESULTS: Colonoscopy: discharge time was significantly shorter in the propofol than the standard group (1.1 ± 0.3 vs. 5 ± 10.2 min, respectively; P=0.03). Endoscopist satisfaction was significantly higher (98.3 ± 11.4/100 vs. 87.2±12/100; P=0.001); patient satisfaction was significantly higher (95 ± 9.3/100 vs. 85.5 ± 14.4/100; P=0.002) in the propofol compared to the standard group. EGD: discharge time was not significantly different in the propofol and standard groups (1.1 ± 0.7 vs. 3.9 ± 9.2 min, respectively; P=0.146). Endoscopist satisfaction was significantly higher (92.7 ± 14.3/100 vs. 82.8 ± 21.2/100; P=0.03); patient satisfaction was significantly higher (93.8 ± 18.2/100 vs. 76.5 ± 25.2/100; P=0.003). In the propofol group 94.3% of patients vs. 71.4% of patients in standard group asked to receive the same sedation in the future (P=0.021). CONCLUSION: Target Controlled Infusion is a promising method for non-anaesthesiologist-administered propofol sedation.

Two dosages of remifentanil for patient-controlled analgesia vs. meperidine during colonoscopy: a prospective randomized controlled trial.

UNLABELLED: BACKGROUND AND STUDY: Combined use of opiates and benzodiazepines often results in delayed discharge after colonoscopy. AIMS: To compare sedation quality of two dosages of patient controlled analgesia remifentanil with one another and with that of a midazolam-meperidine association during colonoscopy. METHODS: Ninety patients undergoing colonoscopy were randomly assigned to three groups. Group M received a meperidine bolus (0.7 mg/kg) and sham patient controlled analgesia. Group R1 received remifentanil 0.5 µg/kg and group R2 remifentanil 0.8 µg/kg together with a patient-controlled analgesia pump injecting further boluses (2-min lock-out). Technical difficulties of the examination, gastroenterologist's and patient's satisfaction with sedoanalgesia were evaluated after colonoscopy on a 100 mm Visual Analogue Scale. Patient's satisfaction was assessed 24 h later. RESULTS: Group M had more adverse events (p = 0.044), required more rescue boluses (p = 0.0010), had lower Observer's Assessment of Alertness and Sedation Scale score at the end of the procedure (p = 0.0016) and longer discharge time (p = 0.0001). Groups R1 and R2 did not differ with respect to these variables. Patient's degree of pain and satisfaction with sedo-analgesia, endoscopist's technical difficulty and satisfaction were not different among groups. CONCLUSIONS: Remifentanil patient controlled analgesia is a safe approach to sedation for colonoscopy.

Adverse events during monitored anesthesia care for GI endoscopy: an 8-year experience.

BACKGROUND: The importance of sedation during endoscopy is well established. There is no consensus about the best techniques for sedation, which specialist should perform it, and in which location. OBJECTIVE: To provide data on the epidemiology of adverse events during sedation for endoscopy. DESIGN: Retrospective analysis of a prospective database. SETTING: Endoscopy unit of a university hospital. PROCEDURES: A total of 17,999 procedures performed over 8 years. INTERVENTIONS: Sedation for GI endoscopy. MAIN OUTCOME MEASUREMENTS: We recorded the following information: sex, age, body mass index, smoking habits, American Society of Anesthesiologists and Mallampati scores, duration of the procedure, type of sedative drug administered, whether the procedure was performed emergently, and endoscopic interventions during the maneuver. Adverse events were defined as occurrences that warranted intervention and were classified as hypotension, desaturation, bradycardia, hypertension, arrhythmia, aspiration, respiratory depression, vomiting, cardiac arrest, respiratory arrest, angina, hypoglycemia, and/or allergic reaction. RESULTS: Deep sedation with intravenous propofol target controlled infusion pump was the most frequently used means of administering sedation. Adverse events were rare in both the adult (4.5%) and pediatric (2.6%) populations. Six complications occurred in more than 0.1% of adult cases: arterial hypotension, desaturation, bradycardia, arterial hypertension, arrhythmia, and aspiration. Only bradycardia (2.1%) and hypotension (0.44%) occurred in children. Three adult patients (0.017%) died, and no pediatric patients died. Some predictive models for the occurrence of complications are proposed. LIMITATIONS: Retrospective analysis, single-center data collection. CONCLUSIONS: Deep sedation during endoscopic procedures is safe in both adults and children. Our data may be useful for the future planning of new clinical strategies in this setting.

Sedation and monitoring for gastrointestinal endoscopy: A nationwide web survey in Italy.

BACKGROUND: Best strategy of sedation/analgesia in gastrointestinal (GI) endoscopy is still debated. AIMS OF THE STUDY: To evaluate sedation and monitoring practice among Italian gastroenterologists and to assess their opinion about non-anaesthesiologist propofol administration. METHODS: A 19-item survey was mailed to all 1192 members of the Italian Society of Digestive Endoscopy (SIED). For each respondent were recorded demographic data, medical specialty, years of practise and practise setting. RESULTS: A total of 494 SIED members returned questionnaires, representing a response rate of 41.4%. The most employed sedation pattern was benzodiazepines for oesophagogastroduodenoscopies (EGDS) in 50.8% of procedures, benzodiazepines plus opioids for colonoscopy and enteroscopy in 39.5% and 35.3% of procedures, respectively, propofol for endoscopic retrograde colangiopancreatography (ERCP) and endoscopic ultrasound (EUS) in 42.3% and 35.6% of procedures, respectively. With regard to propofol use, 66% respondents stated that propofol was exclusively administered by anaesthesiologists. However, 76.9% respondents would consider non-anaesthesiologist propofol administration after appropriate training. Pulse oximetry is the most employed system for procedural monitoring. Supplemental O(2) is routinely administered by 39.3% respondents. CONCLUSIONS: Use of sedation has become a standard practise during GI endoscopy in Italy. Pattern varies for each type of procedure. Pulse oximetry is the most employed system of monitoring. Administration of propofol is still directed by anaesthesiologists.

Remifentanil vs. meperidine for patient-controlled analgesia during colonoscopy: a randomized double-blind trial.

OBJECTIVES: The aim was to compare patients' and endoscopists' satisfaction in terms of efficacy and safety of remifentanil patient-controlled analgesia (PCA) during colonoscopy with that of a combination of midazolam and meperidine. METHODS: Sixty patients undergoing colonoscopy were randomly assigned to two groups. All of the patients received midazolam 0.03 mg/kg intravenously for premedication. In the remifentanil group, a bolus dose of remifentanil was given, and a patient-controlled sedation analgesia (PCSA) pump was set to inject further bolus doses with no "lockout" time. Patients in the meperidine group received a bolus of meperidine and sham PCSA. Non-invasive arterial blood pressure, electrocardiography, and pulse oximetry were monitored throughout the study. The Observer's Assessment of Alertness and Sedation Scale (OAA/S) was performed at baseline, every 5 min during, and after colonoscopy. Assessment of pain and satisfaction with sedoanalgesia was scheduled after colonoscopy and 24-72 h later by a 100 mm visual analog scale (VAS). The technical difficulty of the examination and the gastroenterologist's satisfaction were assessed similarly. RESULTS: The degree of pain, the level of satisfaction with sedoanalgesia by patients and gastroenterologists, and the degree of difficulty experienced by the endoscopist were not different in the two groups. The time to reach an Aldrete score > or = 9 was significantly shorter in the remifentanil group (P < 0.0001); discharge times did not differ between the groups (P = 0.36). There was no difference between the groups regarding the duration of colonoscopy (P = 0.82) and the stability of vital signs. At the end of the procedure, OAA/S was significantly higher in the remifentanil group (P = 0.03). CONCLUSIONS: Remifentanil PCA is safe and effective to induce sedoanalgesia during colonoscopy. Further studies should address the optimization of dosing and lock out setting.

Target-controlled propofol infusion during monitored anesthesia in patients undergoing ERCP.

BACKGROUND: A target-controlled infusion system automatically adjusts the rate of infusion of propofol to maintain a desired (target) concentration. The aim of this study was to determine whether administration of propofol with a target-controlled infusion system could improve the sedation of patients undergoing ERCP. METHODS: A total of 205 consecutive patients undergoing ERCP were sedated by using a propofol target-controlled infusion system by an anesthesiologist. The target plasma concentration of propofol ranged from 2 to 5 microg/mL. A bolus dose of fentanyl (50-100 mcg) was administered if signs of insufficient analgesia were observed at the maximum target concentration of propofol allowed. The technical difficulty of ERCP was graded on a scale from 1 (least difficult) to 5 (most difficult). RESULTS: The mean dosages of propofol and fentanyl administered were 465 (245) mg and 59 (23) mcg, respectively. The total dose of propofol administered and the mean duration of ERCP were related to the degree of difficulty of the procedure. No severe complication was observed; mean time to discharge was 31 (12) minutes. Time to discharge was not influenced by the difficulty of ERCP or by the total dose of propofol administered. CONCLUSIONS: A target-controlled infusion system for administration of propofol provides safe and effective sedation during ERCP. Further studies are needed to determine the cost-effectiveness and the safety profile for infusion of propofol with a target-controlled infusion system by a nonanesthesiologist during ERCP.