A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients.

BACKGROUND AND AIMS: ERCP is a complex procedure often performed in patients at high risk for sedation-related adverse events (SRAEs). However, there is no current standard of care with regard to mode of sedation and airway management during ERCP. The aim of this study was to assess the safety of general endotracheal anesthesia (GEA) versus propofol-based monitored anesthesia care (MAC) without endotracheal intubation in patients undergoing ERCP at high risk for SRAEs. METHODS: Consecutive patients undergoing ERCP at high risk for SRAEs at a single center were invited to participate in this randomized controlled trial comparing GEA and MAC. Inclusion criteria were STOP-BANG score ≥3, abdominal ascites, body mass index ≥35, chronic lung disease, American Society of Anesthesiologists class >3, Mallampati class 4 airway, and moderate to heavy alcohol use. Exclusion criteria were preceding EUS, emergent ERCP, tracheostomy, unstable airway, gastric outlet obstruction or delayed gastric emptying, and altered foregut anatomy. The primary endpoint was composite incidence of SRAEs: hypoxemia, use of airway maneuvers, hypotension requiring vasopressors, sedation-related procedure interruption, cardiac arrhythmia, and respiratory failure. Secondary outcomes included procedure duration, cannulation success, in-room time, and immediate adverse events. RESULTS: Two hundred patients (mean age, 61.1 ± 13.6 years; 36.5% women) were randomly assigned to GEA (n = 101) or MAC (n = 99) groups. Composite SRAEs were significantly higher in the MAC group compared with the GEA group (51.5% vs 9.9%, P < .001). This was primarily driven by the frequent need for airway maneuvers in the MAC group. Additionally, ERCP was interrupted in 10.1% of patients in the MAC group to convert to GEA because of respiratory instability refractory to airway maneuvers (n = 8) or significant retained gastric contents (n = 2). There were no statistically significant differences in cannulation, in-room, procedure, or fluoroscopy times between the 2 groups. All patients undergoing GEA were successfully extubated in the procedure room at completion of ERCP, and Aldrete scores in recovery did not differ between the 2 groups. There were no immediate adverse events. CONCLUSION: In patients at high risk for SRAEs undergoing ERCP, sedation with GEA is associated with a significantly lower incidence of SRAEs, without impacting procedure duration, success, recovery, or in-room time. These data suggest that GEA should be used for ERCP in patients at high risk for SRAEs (Clinical trial registration number: NCT02850887.).

Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures.

BACKGROUND: There are limited data on the safety of anesthesia-assisted endoscopy by using propofol-mediated sedation in obese individuals undergoing advanced endoscopic procedures (AEPs). OBJECTIVE: To study the association between obesity (as measured by body mass index [BMI]) and the frequency of sedation-related complications (SRCs) in patients undergoing AEPs. DESIGN: Prospective cohort study. SETTING: Tertiary referral center. PATIENTS: A total of 1016 consecutive patients undergoing AEPs (BMI <30, 730 [72%]; 30-35, 159 [16%]; >35, 127 [12%]). INTERVENTION: Monitored anesthesia sedation with propofol alone or in combination with benzodiazepines and/or opioids. MAIN OUTCOME MEASUREMENTS: SRCs, airway maneuvers (AMs), hypoxemia, hypotension requiring vasopressors, and early procedure termination were compared across 3 groups. RESULTS: There were 203 AMs in 13.9% of patients, hypoxemia in 7.3%, need for vasopressors in 0.8%, and premature termination in 0.6% of patients. Increasing BMI was associated with an increased frequency of AMs (BMI <30, 10.5%; 30-35, 18.9%; >35-26.8%; P < .001) and hypoxemia (BMI <30, 5.3%; 30-35, 9.4%; >35, 13.4%; P = .001); there was no difference in the frequency of need for vasopressors (P = .254) and premature termination of procedures (P = .401). On multivariable analysis, BMI (odds ratio [OR] 2.0; 95% CI, 1.3-3.1), age (OR 1.1; 95% CI, 1.0-1.1), and American Society of Anesthesiologists class 3 or higher (OR 2.4; 95% CI, 1.1-5.0) were independent predictors of SRCs. In obese individuals (n = 286), there was no difference in the frequency of SRCs in patients receiving propofol alone or in combination (P = .48). LIMITATIONS: Single tertiary center study. CONCLUSIONS: Although obesity was associated with an increased frequency of SRCs, propofol sedation can be used safely in obese patients undergoing AEPs when administered by trained professionals.

Incidence of sedation-related complications with propofol use during advanced endoscopic procedures.

BACKGROUND & AIMS: Propofol is an effective sedative in advanced endoscopy. However, the incidence of sedation-related complications is unclear. We sought to define the frequency of sedation-related adverse events, particularly the rate of airway modifications (AMs), with propofol use during advanced endoscopy. We also evaluated independent predictors of AMs. METHODS: Patients undergoing sedation with propofol for advanced endoscopic procedures, including endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, and small-bowel enteroscopy, were studied prospectively. Sedative dosing was determined by a certified registered nurse anesthetist with the goal of achieving deep sedation. Sedation-related complications included AMs, hypoxemia (pulse oximetry [SpO(2)] < 90%), hypotension requiring vasopressors, and early procedure termination. AMs were defined as chin lift, modified face mask ventilation, and nasal airway. We performed a regression analysis to compare characteristics of patients requiring AMs (AM+) with those who did not (AM-). RESULTS: A total of 799 patients were enrolled over 7 months. Procedures included endoscopic ultrasound (423), endoscopic retrograde cholangiopancreatography (336), and small-bowel enteroscopy (40). A total of 87.2% of patients showed no response to endoscopic intubation. Hypoxemia occurred in 12.8%, hypotension in 0.5%, and premature termination in 0.6% of the patients. No patients required bag-mask ventilation or endotracheal intubation. There were 154 AMs performed in 115 (14.4%) patients, including chin lift (12.1%), modified face mask ventilation (3.6%), and nasal airway (3.5%). Body mass index, male sex, and American Society of Anesthesiologists class of 3 or higher were independent predictors of AMs. CONCLUSIONS: Propofol can be used safely for advanced endoscopic procedures when administered by a trained professional. Independent predictors of AMs included male sex, American Society of Anesthesiologists class of 3 or higher, and increased body mass index.

Prospective evaluation of anesthetic technique for anorectal surgery.

PURPOSE: Deep intravenous sedation plus local anesthesia for anorectal surgery in the prone position is used frequently at our institution, but is not widely accepted because of concerns regarding airway management. The purpose of this study was to prospectively evaluate the safety and efficacy of this anesthetic technique for anorectal surgery. METHODS: Data were collected prospectively on 413 consecutive patients (mean age, 47 years; mean weight, 80 kg) undergoing anorectal surgical procedures. RESULTS: Of the 389 patients who underwent anorectal procedures in the prone position, 260 (67 percent) received intravenous sedation plus local anesthesia, 125 (32 percent) received regional anesthesia (spinal or epidural), and 4 (1 percent) received general endotracheal anesthesia. Of the 24 patients who underwent anorectal procedures in the lithotomy position, 13 (54 percent) received intravenous sedation plus local anesthesia, 2 (8 percent) received regional anesthesia, 2 (8 percent) received general endotracheal anesthesia, and 7 (29 percent) received mask inhalational anesthesia. Forty-two adverse events attributable to the anesthetic occurred in 18 patients: nausea and vomiting (n = 17), transient hypotension, bradycardia, or arrhythmia (n = 8), transient hypoxia or hypoventilation (n = 7), urinary retention (n = 6), and severe patient discomfort (n = 2). These complications occurred in 4 percent (10/273) of patients receiving intravenous sedation plus local anesthesia and in 6 percent (8/127) of patients receiving regional anesthesia. Two of 260 patients (0.8 percent) receiving intravenous sedation plus local anesthesia in the prone position were rolled supine before completing the surgical procedure. Recovery time before discharge for patients treated on an ambulatory basis was significantly shorter for those patients undergoing intravenous sedation plus local anesthesia (79 +/- 34 minutes, n = 174) than for patients undergoing regional anesthesia (161 +/- 63 minutes, n = 45; P < 0.001, t-test). CONCLUSION: Intravenous sedation plus local anesthesia in the prone position is safe and effective for anorectal surgery and offers potential cost savings by decreasing recovery room time for outpatient procedures.