Status:

UNKNOWN

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

Lead Sponsor:

King Abdullah Medical City

Conditions:

Anesthesia

Eligibility:

All Genders

18+ years

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 wh...

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

September 8 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 20 2022

Estimated Enrollment :

204 Patients enrolled

Trial Details

Trial ID

NCT04099693

Start Date

September 8 2019

End Date

May 20 2022

Last Update

April 6 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

King Abdullah Medical City, Holy Capital

Mecca, Makkah Western, Saudi Arabia, 21955