A comparison of propofol versus dexmedetomidine in ERCP patients

Not yet recruiting

• Conditions: Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (3) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,

• Registration Number: CTRI/2020/04/024711
• Lead Sponsor: Amrita Institute of Medical Sciences

Brief Summary

Propofol is widely used for conscious sedation procedures in endoscopic retrograde cholangiopancreatography but can sometimes result in apnea during and after the infusion.

Dexmedetomidine is an alpha agonist with sedative effects being used widely in a number of clinical situations. Among its advantages is the preservation of respiration even under sedative doses.



We propose to evaluate the infusion of a standard dose of propofol with infusion dose of dexmedetomidine in achieving a comparable level of sedation in patients undergoing this procedure. We also aim to look at any adverse effects such as hypotension, bradycardia, and apnea during this procedure and the recovery profile of patients in either group.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-04-16
• Study Start: 2020-04-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with ASA I to III, belonging to age group 18-65 years scheduled for elective ERCP procedure.

Exclusion Criteria

• Duration of procedure >2 hours 2.
• Severe Cardiac, Pulmonary, CNS and Renal disorders 3.
• Allergic to study medications.
• 4.Habituation to Sedative drugs.
• Morbid obesity.
• 6.Refusal to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken to achieve satisfactory sedation Ramsay sedation Score (RSS 3-4) using an infusion of dexmedetomidine versus propofol infusion	Start of infusion until RSS of 3-4.

Secondary Outcome Measures

Name	Time	Method
1. Number of times additional boluses are administered and dosing needed.	2.To note the time taken for recovery (from discontinuation of the study drug till achieving Modified Aldrete Score 9-10

Trial Locations

Locations (1)

Amrita Institute of Medical Sciences; 🇮🇳 Ernakulam, KERALA, India

Amrita Institute of Medical Sciences

🇮🇳Ernakulam, KERALA, India

Lakshmi Kumar

Principal investigator

9496211333

lakshmi.k.238@gmail.com