| CTRI Number |
CTRI/2024/12/078531 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare effects between two antiemetics and find which antiemetic gave better results when given before induction of anesthesia |
|
Scientific Title of Study
|
Comparison Of Ondansetron and Granisetron in Prevention of Post Operative Nausea and Vomiting in Patients undergoing Surgery Under General Anaesthesia at a Tertiary Care Centre |
| 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 KRISHNAKANT BIBHISHAN THOMBRE |
| Designation |
Junior Resident |
| Affiliation |
Vilasrao Deshmukh Government Medical College |
| Address |
Department of Anaesthesia, Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,
Latur
MAHARASHTRA
India
Department of Anaesthesia , Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,
Latur
MAHARASHTRA
India
Latur
MAHARASHTRA
413512
India |
| Phone |
9673635246 |
| Fax |
|
| Email |
krishnakantthombre1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joshi Vyankatesh Shridharacharyaa |
| Designation |
Associate Professor |
| Affiliation |
Vilasrao Deshmukh Government Medical College |
| Address |
Department of Anaesthesia, Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,
Latur
MAHARASHTRA
India
Department of Anaesthesia, Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,
Latur
MAHARASHTRA
India
Latur
MAHARASHTRA
413512
India |
| Phone |
9049481707 |
| Fax |
|
| Email |
vyankatesh93@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joshi Vyankatesh Shridharacharyaa |
| Designation |
Associate Professor |
| Affiliation |
Vilasrao Deshmukh Government Medical College |
| Address |
Department of Anaesthesia, Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,
Latur
MAHARASHTRA
India
Department of Anaesthesia, Vilasrao Deshmukh Government Medical College, Near Rajasthani Marwadi School, Government Medical College Campus,
Latur
MAHARASHTRA
India
Latur
MAHARASHTRA
413512
India |
| Phone |
9049481707 |
| Fax |
|
| Email |
vyankatesh93@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Vilasrao Deshmukh Government medical college,civil hosiptal, Latur, Maharshtra-413512, India |
|
|
Primary Sponsor
|
| Name |
Vilasrao Deshmukh Government medical college,Latur |
| Address |
civil hospital, Latur, Maharshtra-413512, India |
| Type of Sponsor |
Government 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 KRISHNAKANT BIBHISHAN THOMBRE |
Department of Anesthesia |
ENT OT, Obstetric and Gynecology OT,general surgery OT,First Floor,VDGMC
Latur
MAHARASHTRA |
9673635246
krishnakantthombre1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMC, Latur, MH |
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 |
| Intervention |
ondansetron and granisteron |
intravenous route of drug administration dosage ondansetron 4 mg,granisteron 2mg for post operative sugrical cases. |
| Comparator Agent |
To compare and study the efficacy and adverse effects of ondansetron and granisteron |
4mg of ondansetron and 2 mg of granisteron preoperatively of administering general anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)American Society of Anesthesiologists (ASA)Physical status I and II.
2)Age between 18-60 years of either sex.
3)Patients Undergoing Elective Surgeries under General anesthesia |
|
| ExclusionCriteria |
| Details |
1)Age more than 60 or less than 18 years.
2)Patient Of ASA grade 3 and above.
3)Those not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Proportion of Participants achieving PONV score of 3 at 30 minutes to 48 hours with ondansetron and granisetron. |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore any clinical factors that may influence treatment response. |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
02/01/2025 |
| 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="6"
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
|
Objective: To compare the efficacy and incidence of ondansetron and granisetron for control of PONV in patients undergoing surgery under general anesthesia and to study and compare adverse effects caused by these drugs. Methods: Informed consent will be obtained, and data on demographics, comorbidities, and clinical findings will be recorded. Patients will fast for 8–10 hours and complete a pre-anesthetic interview. Baseline vitals will be recorded before surgery.Participants will be randomized using sealed envelopes Group 1 : 2 mg Granisetron IV 2 minutes before induction and Group 2: 4 mg Ondansetron IV 2 minutes before induction.Anesthesia will be induced with Propofol and Scholine, maintained with nitrous oxide, oxygen, and isoflurane, with Vecuronium as needed. Post-surgery, reversal agents will be given, and patients extubated. PONV scores and vitals will be monitored at regular intervals (30 min, 1, 6, 12, 24, 48 hours) postoperatively by a blinded observer. This study compares the effectiveness of Ondansetron and Granisetron, two commonly used antiemetic drugs, in preventing postoperative nausea and vomiting (PONV) in patients undergoing surgery under general anesthesia. By evaluating their efficacy, duration of action, safety profiles, and patient outcomes, the research aims to guide the selection of the optimal antiemetic for improved postoperative care and patient satisfaction.
|