| CTRI Number |
CTRI/2025/05/086887 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing sedation effect of combination of ketamine with propofol and ketamine with dexmedetomidine in cases of upper GI endoscopy . |
|
Scientific Title of Study
|
Comparison of intravenous ketamine with propofol versus ketamine with dexmedetomidine for procedural sedation in upper GI endoscopy |
| 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 Catherine Singh |
| Designation |
Junior resident |
| Affiliation |
Peoples College of medical science and research center |
| Address |
Room 1 1st floor Anaesthesia department peoples hospital bhanpur
Bhopal Madhya Pradesh
462037
India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9806543342 |
| Fax |
|
| Email |
drcatherinesingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Agrawal |
| Designation |
Professor |
| Affiliation |
Peoples College of medical science and research center |
| Address |
Room no .2 first floor Anaesthesia department peoples hospital bhanpur bhopal madhya pradesh 462037 India
Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8989147838 |
| Fax |
|
| Email |
akankshaagarwal2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Agrawal |
| Designation |
Professor |
| Affiliation |
Peoples College of medical science and research center |
| Address |
Room no .2 first floor Anaesthesia department peoples hospital bhanpur bhopal madhya pradesh 462037 India
Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8989147838 |
| Fax |
|
| Email |
akankshaagarwal2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples hospital , peoples College of medical science, karond bypass road bhanpur, Bhopal Madhya pradesh 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples College of medical science and research center |
| Address |
Peoples university karond bypass road, bhanpur, bhopal madhya pradesh 462037 |
| 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 Catherine Singh |
Peoples Hospital |
Room no.1 1st floor peoples hospital karond bypass road Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH |
09806543342
drcatherinesingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee PCMS and RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine with dexmedetomidine for sedation in endoscopic procedures |
All patients for elective UGI Endoscopy will be given ketamine with dexmedetomidine for procedural sedation |
| Intervention |
Ketamine with propofol for sedation in endoscopy procedures |
All patients for elective UGI Endoscopy for procedural sedation will be given ketamine with propofol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist grade 1, 2 and 3
Patients for elective UGI Endoscopy |
|
| ExclusionCriteria |
| Details |
Patients not giving consent
ASA grade more than 3
Patients with cardiac risk
Patients with shock
Patients with severe hepatorenal impairment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure variability |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation |
20 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/06/2025 |
| 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="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
|
For this study elective patients for Upper GI endoscopy will be divided in 2 groups for procedural sedation .1 group will be receiving intravenous ketamine with propofol for sedation and the 2nd group will be receiving ketamine with dexmedetomidine for sedation .Both the groups will then be compared for haemodynamic changes - blood pressure and pulse and Ramsay sedation score and recovery time .ketamine will be the base drug and will be given in a dose of 1 mg/kg .propofol will be given in a dose of 1 mg/kg and a maintenance dose of 0.25 mg/kg while dexmedetomidine will be given in a dose of 0.5 mcg/ kg and a maintenance dose of 0.1 mcg/ kg . In case adequate sedation is not achieved ketamine will be given in dose of 0.25 mg/ kg . Patients in both groups will also be assessed for recovery time along with Ramsay sedation score and haemodynamic changes. |