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CTRI Number  CTRI/2025/09/094223 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Efficacy of Ondansetron for the reduction of Propofol injection pain, A prospective Randomized Controlled Trial 
Scientific Title of Study   Efficacy of Ondansetron with and without venous occlusion in the reduction of Propofol injection pain, A Double Blind Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Dwivedi 
Designation  Associate Professor 
Affiliation  AIIMS Gorakhpur 
Address  Department of Anaesthesia AIIMS GKP
OT Complex Department of Anaesthesiology Pain & Critical Care Medicine All India Institute of Medical Sciences
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  08795453444  
Fax    
Email  drpriyad1111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priyanka Dwivedi 
Designation  Associate Professor 
Affiliation  AIIMS Gorakhpur 
Address  Department of Anaesthesia AIIMS GKP
OT Complex Department of Anaesthesiology Pain & Critical Care Medicine All India Institute of Medical Sciences
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  08795453444  
Fax    
Email  drpriyad1111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka Dwivedi 
Designation  Associate Professor 
Affiliation  AIIMS Gorakhpur 
Address  Department of Anaesthesia AIIMS GKP
OT Complex Department of Anaesthesiology Pain & Critical Care Medicine All India Institute of Medical Sciences
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  08795453444  
Fax    
Email  drpriyad1111@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Gorakhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Gorakhpur 
Address  All India Institute of Medical Sciences, Gorakhpur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priyanka Dwivedi  OT Complex AIIMS Gorakhpur  Department of Anaesthesia, AIIMS GKP Department of Anaesthesiology, Pain & Critical Care Medicine All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH 		 08795453444

drpriyad1111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional human ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adult patients visiting AIIMS Gorakhpur scheduled for elective surgery under general anaesthesia with propofol induction who are found to be as per the inclusion criteria will be enrolled in the study will be give inj ondem with venous occlusion  GROUP A - These patients will receive 4 mg Ondansetron (2 ml) with venous occlusion. 
Comparator Agent  Adult patients visiting AIIMS Gorakhpur scheduled for elective surgery under general anaesthesia with propofol induction who are found to be as per the inclusion criteria will be enrolled in the study will be given ondem without venous occlusion  GROUP B - These patients will receive 4 mg Ondansetron (2 ml) without venous occlusion.  
Comparator Agent  Adult patients visiting AIIMS Gorakhpur scheduled for elective surgery under general anaesthesia with propofol induction who are found to be as per the inclusion criteria will be enrolled in the study will given NS  GROUP C - These patients will receive 0.9% sodium chloride solution (2 ml) without venous occlusion.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 18 - 60 years old, of either sex, physical status (ASA) I and II, who are scheduled for elective surgery under general anaesthesia with propofol induction with 20-gauge IV cannula at the dorsum of hand prior to surgery. 
 
ExclusionCriteria 
Details  Patient refusal, Patients allergic to ondansetron, lignocaine or propofol,Patients who did not receive propofol for induction,Patients who used apomorphine, dronedarone, monoamine oxidase inhibitors and serotonergic drugs, Patients with cardiac arrhythmia like prolonged QT Syndrome or 2nd/3rd degree AV Block, Patients who had chronic pain , Patients who did not have 20G IV Cannula on the dorsum of the hand, Patients who received rapid sequence intubation technique.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of propofol injection pain in the three study groups.
 		 At the time of giving injection
 
 
Secondary Outcome  
Outcome  TimePoints 
Severity of propofol injection pain in the three study groups.  till post operative 2 hours 
Incidence of postoperative nausea & vomiting in the three study groups,  till post operative 2 hours 
Incidence of adverse effects, if any.  till post operative 2 hours 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
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)   15/10/2025 
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="1"
Months="1"
Days="1" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drpriyad1111@gmail.com].

  6. For how long will this data be available start date provided 03-09-2025 and end date provided 03-09-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This double-blind randomized controlled trial aims to evaluate the efficacy of ondansetron pretreatment with and without venous occlusion in preventing propofol injection pain. A total of 174 adult patients undergoing elective surgery at AIIMS Gorakhpur will be enrolled. After standard monitoring and pre-oxygenation, patients will receive the allocated intervention, followed by a standardized propofol infusion. Pain at the injection site will be assessed using the Verbal Numerical Rating Scale. The primary outcome is the incidence of propofol injection pain, while secondary outcomes include pain severity, postoperative nausea and vomiting, and any adverse effects. 
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