| CTRI Number |
CTRI/2023/08/056241 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
05/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
Efficacy and safety during Endoscopic Retrograde Cholangio-Pancreatography under Total Intravenous Anesthesia-Propofol alone versus Propofol supplemented with Dexketa, a comparative study in Medical College Kolkata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debanjana Roy |
| Designation |
RMO cum Clinical Tutor |
| Affiliation |
Medical College Kolkata |
| Address |
D11/6 EKTP Phase IV near Ruby Hospital Kasba Gold Park Kolkata
Departmemt of Anaesthesiology, Green building, Medical College and Hospital,88, College street, Kolkata 700073
Kolkata
WEST BENGAL
700107
India |
| Phone |
8250043098 |
| Fax |
|
| Email |
ukroy10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debasish Ghosh |
| Designation |
Assistant Professor |
| Affiliation |
Medical College Kolkata |
| Address |
7 B N Road Uttarpara Hooghly
Department of Anaesthesiology, Green building, Medical College and hospital,88 College Street Kolkata 700073
Kolkata
WEST BENGAL
712258
India |
| Phone |
9231319202 |
| Fax |
|
| Email |
debasish2801@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debankita Das |
| Designation |
Junior Resident |
| Affiliation |
Medical College Kolkata |
| Address |
6 Raja Pyari Mohan Road, Uttarpara, Hooghly
Department of Anaesthesiology, Green building, Medical College and Hospital, 88, College Street, Kolkata-700073
Kolkata
WEST BENGAL
712258
India |
| Phone |
8420685015 |
| Fax |
|
| Email |
debankita10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Green Building, Medical College and hospital, 88, College street, Kolkata 700073 |
|
|
Primary Sponsor
|
| Name |
Dr Debasish Ghosh |
| Address |
Department of Anesthesiology, Green building, Medical College and hospital, 88, College street, Kolkata-700073 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Debasish Ghosh |
Medical College Kolkata |
Department of Anaesthesiology, Green building, Medical College and hospital, 88, College street, Kolkata 700073
Kolkata
WEST BENGAL |
9231319202
debasish2801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL COLLEGE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K831||Obstruction of bile duct, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol |
Propofol 30mg bolus slow IV, after 10 mins while negotiating scope 50mg slow IV, and then repeated according to requirements throughout the duration of surgery |
| Comparator Agent |
Propofol along with Ketamine and Dexmedetomidine |
0.5mcg/kg body weight Dexmedetomidine given as loading dose over 10 mins IV. Before negotiating scope, 20mg Propofol given slow IV.By this time Dexmedetomidine is started as an infusion dose of 0.3mcg/kg/hr IV. After negotiating scope, 1ml of (1:1) mixture of Ketamine and Propofol is given slow IV every 10 mins and whenever required throughout the duration of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Physical status ASA-PS 1 and ASA-PS 2
Having no anticipated difficult airway |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A decrease in heart rate when Dexmedetomidine is used |
Baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dose of Propofol required will be much less when used along with Ketamine & Dexmedetomidine |
BASELINE 4 WEEKS AND 8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2023 |
| 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="0"
Months="4"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |