| CTRI Number |
CTRI/2025/07/090856 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparision between 2 pain killer drugs in endoscopic surgery |
|
Scientific Title of Study
|
A Comparison between Propofol infusion with Fentanyl and Propofol infusion with Nalbuphine for sedation and analgesia for the patient undergoing UGI scopies and associated procedures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhavi Hajariwala |
| Designation |
Associate Professor of anaesthesiology |
| Affiliation |
Shree krishna hospital, karamsad ,Bhaikaka University |
| Address |
Shree Krishna Hopsital, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9409206121 |
| Fax |
|
| Email |
vaibhavih@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaibhavi Hajariwala |
| Designation |
Associate Professor of anaesthesiology |
| Affiliation |
Shree krishna hospital, karamsad ,Bhaikaka University |
| Address |
Room no 112-Anaesthesia Department at Shree Krishna Hopsital, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9409206121 |
| Fax |
|
| Email |
vaibhavih@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhavi Hajariwala |
| Designation |
Associate Professor of anaesthesiology |
| Affiliation |
Shree krishna hospital, karamsad ,Bhaikaka University |
| Address |
Room no 112-Anaesthesia department at Shree Krishna Hopsital, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9409206121 |
| Fax |
|
| Email |
vaibhavih@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| shree krishna hospital,karamsad, Gokal nagar,Karamsad,Di-Anand,Gujarat ,Pin no -388325 |
|
|
Primary Sponsor
|
| Name |
Shree Krishna Hospital |
| Address |
Shree Krishna Hospital, Karamsad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Archit Prajapati |
Shree Krishna Hospital |
Room no -112,Anesthesiology Department, Shree Krishna Hospital,Karamsad,Gujarat Pin no -388325
Anand
GUJARAT |
9409206121
architprajapati1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee-2 |
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 |
Injection Fentanyl 2mcg/kg IV single dose vs Injection Nalbuphine 0.2mg/kg IV Single dose |
Compare patient movement score and surgeon satisfaction score |
| Intervention |
Injection Propofol 0.15 mg/kg/min IV infusion till procedure ends |
sedation and analgesia, sedation will be given till procedure ends |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients ASA(American society of Anaesthesia)ASA I to ASA III
patients undergoing above mentioned UGI scopies
|
|
| ExclusionCriteria |
| Details |
Patient with known allergy to drug to be injected
Patient with uncontrolled hypertension
Patient with pregnancy
Central nervous system abnormality
Patient with high cardiac risk
Patient with pulmonary disease
Patient with any psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare patient movement score and endoscopist sedation score for sedation and recovery |
To compare patient movement score and endoscopist satisfaction score for sedation and recovery during procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceleration or extra bolus dose of propofol needed,effect on hemodynamics,any episode of desaturation, vas score |
During procedure |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/05/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Comparison between bolus Fentanyl @ 2mcg/kg vs Nalbuphine @ 0.2mg/kg and Propofol infusion started @ 0.15mg/kg/min for sedation and analgesia for the patient undergoing UGl scopies and associated procedures and check intra op vitally and hemodynamically stability, patient movement score and surgeon satisfactory score. |