To compare effect of Dexmedetomidine and Remitentanil in patients posted for Endoscopic Retrograde cholangiography (ERCP)

Phase 4

Not yet recruiting

Registration Number: CTRI/2025/06/089426

Lead Sponsor: Institute of medical science and sum hospital

Brief Summary: This is a Double blinded randomised clinical trial conducted at our institution in ERCP operation theatre

•The data to be collected are all part of routine care. •

All the Data collected will be entered in Microsoft excel 2007 and further analysed in SPSS VERSION-27.

In this study 118 patients between age 18 years to 60 years posted for ERCP procedure are included

With reference from previous study (Propofol-Dexmedetomidine versus Propofol-Ketamine for Anaesthesia of Endoscopic Retrograde Cholangiopancreatography (ERCP) (Comparative Study), The Egyptian Journal of Hospital Medicine (April 2023) Vol.91)

Significance= 0.05

Power= 0.8

Allowable difference= 40

Standard deviation(SD)= 70

Margin= 0

Drop rate(%)= 10

After drop rate sample size: 108

Corrected estimate total sample size: 118, with the help of Cleveland clinic sample size calculator.

After taking written informed consent from patients , patients will be randomized to 2 groups (n= 108 each ) by computer generated random number table. All patients will be thoroughly examined pre-operatively which includes blood pressure, heart rate, respiratory rate and systemic examination, and ASA grading. The patients with a contraindication to procedure like allergic reaction to any drugs, major neurological, cardiovascular, psychology, respiratory abnormalities will be excluded

Physiological parameters such as Heart Rate, Respiratory rate, Oxygen saturation and non invasive blood pressure will be monitored continuously, at the beginning of the procedure, on the first, fifth minute and every 5 minutes until the transfer of the patient to the post anaesthetic care unit. Level of sedation will be assessed using Ramsay sedation score at the end of the Procedure and 1 hour after the procedure in the post anaesthetic care unit. Patients will be observed for occurrence of any side effects like nausea, vomiting, delirium in the post anaesthetic care unit.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 118

Inclusion Criteria

Patients age between 18 to 60 undergoing for ERCP 2) ASA physical status I-II.

Exclusion Criteria

Neurological disease 2) Psychiatric disease 3) Cardiovascular disease (Arrhythmia, Heart failure, coronary artery disease) 4) Anticipated difficult airway 5) Pulmonary disease (asthma, COPD) 6) Pregnant patients 7) Known allergy to study drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the dose of Propofol during procedure	Duration of Surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of side effect (Nausea, Vomiting and Delirium)	Post operative period for 1 hour
Incidence of Respiratory depression (SpO2 less than less 90% or Respiratory rate less than 8 per minute)	Duration of Surgery
To evaluate	Haemodynamic stability (MAP, Heart Rate)
Ramsay sedation score	At the end of procedure and at 1 hour post operative period

Trial Locations

Locations (1): Institute of medical sciences , Siksha o Anusadhan
🇮🇳
Khordha, ORISSA, India
Institute of medical sciences , Siksha o Anusadhan
🇮🇳Khordha, ORISSA, India
Dr Deep Trambadiya
Principal investigator
9537492082
deep21patel96@gmail.com