Clinical trial NCT04099693: A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Official title: A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Lead sponsor: King Abdullah Medical City
Sponsor class: OTHER_GOV
First posted: 2019-09-23
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients referred for ERCP who meet the below criteria will be approached to participate in the study

Brief summary: Currently there no standard sedation techniques for performing ERCP. It is not clear whether sedation administered by anesthetist is better than anesthesia with intratracheal intubation. To clarify which of these sedative methods are better we plan to conduct a randomized trial comparing anesthetist administered sedation with general anesthesia in patients with ASA ≤3.

Detailed description: ERCP is a relatively complex and lengthy endoscopic procedure. It is increasingly performed in elderly patients with multiple comorbidities and carries serious complications including death in about 0.33% of patients. An important aspect of endoscopy is sedation. The role of sedation is to make the procedure tolerable and acceptable to the patient by reducing anxiety and discomfort. It ensures that the patient is relatively still to avoid injury and enhance the chances of an efficient and successful procedure. Hence, adequate and appropriate sedation is of utmost importance to maximize patient comfort and minimize adverse events in ERCP.

The debate between anesthetist and gastroenterologist continues, as there is dearth of evidence evaluating the best form of sedative technique for ERCP.

Three prospective studies have tried to compare AAS with general anesthesia. Despite the fact that significantly more patients who had a higher body mass index (BMI) and were of ASA class 3 and above in the general anesthesia group, hypoxic events of less than 84% were much more common in patients having AAS then those who had general anesthesia (15% in AAS vs 6.7% in general anesthesia). On the other hand, hypotension (34% in general anesthesia vs 4% in AAS,) and arrhythmias (8% in general anesthesia vs 3% in AAS) were much more frequent in general anesthesia group than AAS. Upto 4% of patients had to be converted to general anesthesia due to cardiopulmonary compromise. However, the conclusion drawn was that AAS is as safe and effective as general anesthesia. Major caveats bring into question the conclusion. The studies were observational and non-randomized which introduces selection bias.

A recent randomized controlled trail that looked at general anesthesia versu AAS during ERCP concluded general anesthesia had a better safety profile than AAS (17). However, this study included only patient who were high risk for sedation related adverse events with ASA class \>3 and the anesthesia was provided by nurse anesthetist. Hence, these results cannot be generalized. There are no randomized trials comparing AAS with general anesthesia in patients with ASA ≤3, which includes the vast majority of patients having ERCP

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Referred for ERCP
* Assessed by anesthetist
* ASA 1-3

Exclusion Criteria:

* Emergency situation (upper GI bleed, on mechanical ventilation)
* ASA class ≥4
* Distorted anatomy - like partial or total gastrectomy
* Pregnancy
* Unable to give or obtain consent and/ or disturbed level of consciousness
* Suspected difficult intubation using Ganzouri score \> than 5 (18).
* Allergy to any study medication.

Primary outcomes:
measure: The safety of anesthetist administered sedation (AAS) with general anesthesia for ERCP.
timeFrame: 2 years
Secondary outcomes:
measure: -The patient and endoscopist satisfaction with both types of sedation -The recovery time of AAS and general anesthesia
timeFrame: 2 years
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: King Abdullah Medical City, Holy Capital
state: Makkah Western
Study officials:
References:
citation: Alzanbagi AB, Jilani TL, Qureshi LA, Ibrahim IM, Tashkandi AMS, Elshrief EEA, Khan MS, Abdelhalim MAH, Zahrani SA, Mohamed WMK, Nageeb AM, Abbushi B, Shariff MK. Randomized trial comparing general anesthesia with anesthesiologist-administered deep sedation for ERCP in average-risk patients. Gastrointest Endosc. 2022 Dec;96(6):983-990.e2. doi: 10.1016/j.gie.2022.06.003. Epub 2022 Jun 9.