Comparison of safety and efficacy between Propofol alone and Propofol with Ketamine and Dexmedetomidine while being used as an anesthetic agent in TIVA during ERCP procedure

Phase 4

Not yet recruiting

Conditions: Obstruction of bile duct,

Registration Number: CTRI/2023/08/056241

Lead Sponsor: Dr Debasish Ghosh

Brief Summary: Endoscopic Retrograde Cholangio Pancreatography (ERCP) is an invasive procedure and hence is distressing for awake patients, requiring adequate level of anaesthesia. Recent advancements have encouraged use of monitored anaesthesia care (MAC) , that allows the patient to tolerate unpleasant procedures while maintaining cardio-respiratory function. The main aim was to compare the effect of Propofol alone and Propofol with Ketamine and Dexmedetomidine on the hemodynamics during ERCP, recovery profile and side effects (if any).

This is a comparative study. Adult patients from age group of 18-70 years belonging to ASA-I and ASA-II who will undergo ERCP under TIVA (Total Intravenous Anaesthesia) will be taken and will randomly be assigned to either of the two groups. Both groups will receive 0.2mg Glycopyrrolate, 4mg Ondansetron, 1mg Midazolam, 50mcg Fentanyl and 40mg Hyoscine. Group A patients will receive 30mg Propofol as bolus dose and will be repeated according to requirements. Group B patients will receive 0.5mcg/kg Dexmedetomidine as loading dose and 0.3mcg/kg as infusion dose. 20mg Propofol will be given before negotiating scope and then 1ml (1:1) mixture of Propofol and Ketamine will be repeated every 10 minutes. Total Propofol consumption, hemodynamics, quality of recovery and side effects (if any) will be recorded at regular intervals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 66

Inclusion Criteria

Physical status ASA-PS 1 and ASA-PS 2 Having no anticipated difficult airway.

Exclusion Criteria

Patient refusal AKI,CKD,Low Ejection Fraction, Uncontrolled Diabetes Undergoing emergency procedure Known allergy to drugs to be used in the study Previous bleeding disorder or coagulopathy Administration of any sedative or narcotics within 24 hours Duration more than 60 minutes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A decrease in heart rate when Dexmedetomidine is used	Baseline, 4 weeks, 8 weeks

Secondary Outcome Measures

Name	Time	Method
Dose of Propofol required will be much less when used along with Ketamine & Dexmedetomidine	BASELINE 4 WEEKS AND 8 WEEKS

Trial Locations

Locations (1): Medical College Kolkata
🇮🇳
Kolkata, WEST BENGAL, India
Medical College Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Dr Debasish Ghosh
Principal investigator
9231319202
debasish2801@gmail.com