| CTRI Number |
CTRI/2024/04/066242 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of drug Ondansetron for prevention of low blood pressure (hypotension) |
|
Scientific Title of Study
|
Comparison of Efficacy and Safety Profile of PreEmptive Ondansetron and Ephedrine for prevention of hypotension under Spinal Anaesthesia: A Prospective Double blinded 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 |
Dr Ashutosh kumar |
| Designation |
Junior Resident |
| Affiliation |
All India institute of medical sciences Gorakhpur |
| Address |
Department of Anaesthesiology AIIMS Gorakhpur Uttar Pradesh India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9097124093 |
| Fax |
|
| Email |
kashutosh20198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Vardhan |
| Designation |
HOD and Professor |
| Affiliation |
All India institute of medical sciences Gorakhpur |
| Address |
Department of Anaesthesiology AIIMS Gorakhpur Uttar Pradesh India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9323267123 |
| Fax |
|
| Email |
vikram15vardhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh kumar |
| Designation |
Junior Resident |
| Affiliation |
All India institute of medical sciences Gorakhpur |
| Address |
Department of Anaesthesiology AIIMS Gorakhpur Uttar Pradesh India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9097124093 |
| Fax |
|
| Email |
kashutosh20198@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Department of Anaesthesiology
AIIMS Gorakhpur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashutosh kumar |
All India institute of medical sciences Gorakhpur |
Operation theatre (Ot complex),Department of Anaesthesiology
Gorakhpur
UTTAR PRADESH |
9097124093
kashutosh20198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee,All India Institute of Medical Sciences ,Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I952||Hypotension due to drugs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ephedrine |
Patient will receive Ephedrine 6mg diluted to normal saline to make it 5ml total volume given intravenously as bolus ten minutes before giving spinal anaesthesia |
| Intervention |
Group O Ondansetron 8mg with normal saline |
Patient will receive Ondansetron 8mg diluted to normal saline to make it 5ml total volume given Intravenously as bolus ten minutes before giving spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
ASA Class I |
|
| ExclusionCriteria |
| Details |
Patient’s refusal
Infection at the site
Coagulation abnormality
Allergy to study drugs
Patient receiving Ondansetron
Repeat or failed spinal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of the two study drugs for prevention of Incidence of Hypotension |
Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare hemodynamic changes in both the study groups
To compare side effects and complications if any |
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/05/2024 |
| 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
|
This study is a double blind randomised controlled trial comparing efficacy and safety profile of PreEmptive Ondansetron and Ephedrine for prevention of hypotension under spinal anaesthesia in 144patients admitted at AIIMS Gorakhpur for infraumbilical surgeries. Primary outcome is to compare efficacy of two study drugs for prevention of incidence of hypotension.Secondary outcome are to compare hemodynamic changes and to compare side effects and complications if any . |