| CTRI Number |
CTRI/2024/10/075619 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparision of procedural sedation for ERCP using propofol with ketamine versus dexmedetomidine with ketamine based infusion using BIS guided. |
|
Scientific Title of Study
|
BIS guided comparision of procedural sedation for endoscopic retrograde cholangiopancreatography (ERCP)using propofol with ketamine versus dexmedetomidine with ketamine based infusion. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr rohit pareek |
| Designation |
resident |
| Affiliation |
mahatma gandhi medical college and hospital |
| Address |
2nd floor main OT complex department of anesthesia at mahatma gandhi medical college and hospital riico industrial area sitapura jaipur rajasthan
302022
india
Jaipur
RAJASTHAN
302022
India |
| Phone |
9462848382 |
| Fax |
|
| Email |
dr.rohit41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir sachdeva |
| Designation |
Professor |
| Affiliation |
Mahatma gandhi medical college and hospital |
| Address |
2nd floor department of anesthesia HOD office mahatma gandhi medical college and hospital riico industrial area sitapura jaipur rajasthan
302022
india
2nd floor department of anesthesia HOD office medical gandhi medical college and hospital riico industrial area sitapura jaipur rajasthan
302022
india
Jaipur
RAJASTHAN
302022
India |
| Phone |
9314882845 |
| Fax |
|
| Email |
ssmgumst@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
drgaurav goyal |
| Designation |
professor |
| Affiliation |
mahatma gandhi medical college and hospital |
| Address |
2nd floor srcc building OT 3 mahatma gandhi medical college and hospital riico industrial area sitapura jaipur rajasthan
302022
india
Jaipur
RAJASTHAN
302022
India |
| Phone |
9982190343 |
| Fax |
|
| Email |
drgauravgoyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| mahatma gandhi medical college and hospital, jaipur rajasthan |
|
|
Primary Sponsor
|
| Name |
mahatma gandhi medical college and hospital |
| Address |
mahatma gandhi medical college and hospital riico industrial area sitapura jaipur rajasthan
302022
india |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ROHIT PAREEK |
Mahatma gandhi medical college and hospital |
RIICO INDUSTRIAL AREA SITAPURA TONK ROAD JAIPUR
Jaipur
RAJASTHAN |
9462848382
dr.rohit41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RAJENDRA KUMAR SUREKHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIS |
APPLY BI SPECTRAL INDEX TO MONITOR THE DEPTH OF ANAESTHESIA |
| Comparator Agent |
Dexmedetomidine with Ketamine |
AFTER APPLYING BIS TO THE PATIENT AND INDUCE PATIENT WITH DEXMEDETOMIDINE AND KETAMINE AND MONITOR DEPTH OF ANAESTHESIA. |
| Comparator Agent |
PROPOFOL AND KETAMINE |
AFTER APPLYING BIS TO THE PATIENT AND INDUCE PATIENT WITH PROPOFOL AND KETAMINE AND MONITOR DEPTH OF ANAESTHESIA. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade 1 and 11
2.Age between 18years to 65 years scheduled for ERCP 3.All genders |
|
| ExclusionCriteria |
| Details |
1. Patient with preexisting cardiac disease(congestive heart failure,coronary heart disese)
2.Severe renal dysfunction
3.Pregnancy
4.Lactating females
5.Patient with known allergy to drugs
6.Hypertension
7.Increased intracranial tension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare two regimens based on depth of anesthesia using bi spectral index(BIS). |
To compare two regimens based on depth of anesthesia using bi spectral index(BIS). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the quality of anesthesia in terms of hemodynamic stability, pain relief and surgeon’s satisfaction between groups.
To study recovery profile as per ERAS protocol between groups. |
Assessing hemodynamic stability, pain relief and surgeon’s satisfaction between groups and study recovery as per ERAS protocol. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study compares the efficacy and safety of two sedation protocols guided by Bispectral Index (BIS) monitoring for endoscopic retrograde cholangiopancreatography (ERCP): propofol with ketamine versus dexmedetomidine with ketamine infusion. Both protocols aim to optimize sedation depth while minimizing adverse events. By analyzing factors such as sedation efficacy, procedural success rates, patient satisfaction, recovery times, hemodynamic stability, respiratory parameters, and cost-effectiveness, the study seeks to identify the optimal sedation strategy for ERCP. The findings will inform clinical practice and enhance patient outcomes in ERCP procedures. A prospective, hospital based, randomised control trial study including a sample size of 90 patients in a time period between April 2023 to October 2024.
Data will be collected by using self design questionnaire and observational findings during procedure.
Entire data would be entered into a Microsoft office software and appropriate stastical test will be applied and results will be calculated. |