Author: Caroline Helwick
General endotracheal anesthesia may be preferred over sedation with propofol in patients undergoing endoscopic retrograde cholangiopancreatography who are considered at high risk for adverse events from sedation, according to investigators from Washington University School of Medicine in St. Louis.
“In this first prospective randomized trial comparing general endotracheal anesthesia with monitored anesthesia care [MAC] during ERCP, we found that general anesthesia was associated with a significantly lower incidence of sedation-related adverse events [SRAEs], without impacting procedure duration, technical success, recovery time or in-room procedure time,” said Zachary L. Smith, DO, who reported the findings at the 2018 Digestive Disease Week (abstract 935).
In this high-risk cohort, MAC also resulted in more procedure interruptions and the need for conversion to general endotracheal anesthesia in 10% of cases, Dr. Smith added.
Clinicians often perform ERCP in patients at high risk for SRAEs, but there is no standard of care with regard to mode of anesthesia and airway management during the procedures.
The primary end point was the composite incidence of adverse events: hypoxia (blood oxygen saturation, <90%) requiring airway maneuvers, need for conversion to general endotracheal anesthesia, hypotension requiring vasopressors, sedation-related procedure interruption, cardiac arrhythmia, respiratory failure and death. Secondary outcomes included procedure duration, time to cannulation of the duct of interest, technical success of ERCP, room-in to room-out time, and immediate and delayed procedure-related adverse events.
Patients sedated with propofol experienced significantly more SRAEs than those in the group who received general endotracheal anesthesia, with a composite incidence of 51% versus 9% (P<0.001; Table). This difference was driven primarily by the frequent need for airway maneuvers in the sedation group.
|Table. Key Outcomes for ERCP Anesthesia|
|End Point||MAC (n=99)||GEA (n=101)||P Value|
|Clinically significant hypoxia||19||5||0.002|
|Need for airway maneuvers||45||0||<0.001|
|Sedation-related procedure interruptions||10||0||<0.001|
|Hypotension requiring vasopressors||9||10||1.00|
|ERCP, endoscopic retrograde cholangiopancreatography; GEA, general endotracheal anesthesia; MAC, monitored anesthesia care|
ERCP was interrupted in 10% of patients in the sedation group to convert to general endotracheal anesthesia in cases of respiratory instability refractory to airway management or retained gastric contents, Dr. Smith reported.
No statistically significant differences were observed in cannulation success, in-room time, procedure time, fluoroscopy times or use of adjunctive anesthetics between the two groups. All patients undergoing general endotracheal anesthesia were successfully extubated in the procedure room at the completion of ERCP, and Aldrete scores in recovery did not differ between the two groups, the researchers reported.
“There were also no immediate adverse events, but we did observe 10 delayed events: six in the monitored anesthesia care group and four in the general anesthesia group [P=0.49],” he said. These included postprocedural pain requiring hospital admission in four patients, ERCP-related gastrointestinal bleeding in three patients, and post-ERCP pancreatitis in one patient. One patient experienced altered mental status resulting from overuse of opioids three days after ERCP.
Dr. Smith acknowledged that the study was performed in a single center “that is one of high efficiency and volume, with a very experienced anesthesia staff,” so the results may not be generalizable across all health care settings. He said his department has not yet changed practice because of the findings, but said “for any patient with risk factors for sedation-related adverse events, we’ll discuss general anesthesia with the patient and the anesthesia team, since general anesthesia does not negatively affect our efficiency.”
Rahul Pannala, MD, MPH, a gastroenterologist at Mayo Clinic in Phoenix, called the results “striking.”
“MAC was associated with significantly higher risk for sedation-related adverse events and a 10% conversion rate to general anesthesia, with no differences in procedural characteristics or recovery,” Dr. Pannala said. “While there is no universal consensus on the optimal sedation strategy in patients undergoing ERCP, previous single-institution studies and standards of practice note that ERCP can be performed safely using monitored anesthesia without requiring universal intubation. The results of the present study suggest that while universal intubation may not be necessary, general anesthesia may be the safest approach in high-risk patients; therefore, pre-procedure risk stratification of patients is very important.”
Dr. Pannala said the results need further validation, preferably in a multicenter study, and that the use of ancillary methods, such as high-flow oxygen during sedation, might minimize the risk for related adverse events and should be studied.