A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP

NCT04099693 | Unknown

• 1 other identifier: 18-492
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• The safety of anesthetist administered sedation (AAS) with general anesthesia for ERCP.

  Significant cardiopulmonary complications will be defined as 1) Hypotension - when systolic BP drops below 25% of the baseline measurement requiring vasopressor drugs; 2) Cardiac Arrythmia - Bradycardia when heart rate drops below 50 beats/min or rises above 120 beats/min requiring treatment; 3) Hypoxia - when oxygen saturation falls below 90%; 4) Hypercapnia - when expiratory carbon dioxide increase by more than 25% from the baseline; 5) Apnea when respiratory activity ceases for ≥10 seconds via capnography; 6) Any interruption or termination of ERCP procedure related to sedation

  2 years

Secondary Outcomes (1)

• -The patient and endoscopist satisfaction with both types of sedation -The recovery time of AAS and general anesthesia

  2 years

Study Arms (2)

General Anesthesia

All the patients will be intubated and ventilated using cisatracurium (0.15 mg/kg) as a muscle relaxant and propofol (1.5-2mg/kg) for induction. The inhalational anesthetic, sevoflurane, will be used to maintain the depth of anesthesia using 50% mix of nitrous oxide and oxygen. Fentanyl will be used in both groups at a rate of 1-2 microgram /kg to achieve an adequate level of analgesia in both groups.

Anesthetist Administered sedation for ERCP

To ensure a steady level of AAS each patient in this group will be sedated using propofol. An induction bolus of propofol (0.5 - 1 mg/kg) will be administered followed by continuous infusion with variable doses depending on the patients' age, weight, and clinical condition. In addition, fentanyl 1.5 μg/kg will be used at the anesthetist discretion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah Medical City: lead

Study Sites (1)

King Abdullah Medical City, Holy Capital

Mecca, Makkah Western, 21955, Saudi Arabia

RECRUITING

Related Publications (1)

• 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.

  PMID: 35690151 DERIVED

Central Study Contacts

Adnan Zanbagi, MD

CONTACT

+96625549999; Alzanbagi.A2@kamc.med.sa

Mohammad K Shariff, MD

CONTACT

Alzanbagi.A2@kamc.med.sa; Shariff.M@kamc.med.sa

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: September 23, 2019
• Study Start: September 8, 2019
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)