| CTRI Number |
CTRI/2025/03/083055 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Trial to compare two drugs used to prevent complications of post operative nausea and vomiting after neurosurgery |
|
Scientific Title of Study
|
COMPARISON OF INTRAVENOUS ONDANSETRON VERSUS COMBINATION OF INTRAVENOUS ONDANSETRON AND ORAL APPREPITANT TO PREVENT POST OPERATIVE NAUSEA VOMITING IN PATIENTS UNDERGOING ELECTIVE CRANIOTOMIES – A PROSPECTIVE RANDOMISED CONTROL 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 |
DrVanchula Srinivasan |
| Designation |
Post Doctoral Fellow - Neuroanaesthesiology |
| Affiliation |
Kauvery Institute of Brain and Spine, Kauvery Hospital,Radial Road |
| Address |
Department of Neuroanaesthesiology and Critical Care,
Kauvery Hospital,Radial Road,
Chennai.
Chennai
TAMIL NADU
600129
India |
| Phone |
9940672171 |
| Fax |
|
| Email |
drvanchula@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrVanchula Srinivasan |
| Designation |
Post Doctoral Fellow - Neuroanaesthesiology |
| Affiliation |
Kauvery Institute of Brain and Spine, Kauvery Hospital,Radial Road |
| Address |
Department of Neuroanaesthesiology and Critical Care,
Kauvery Hospital,Radial Road,
Chennai.
Chennai
TAMIL NADU
600129
India |
| Phone |
9940672171 |
| Fax |
|
| Email |
drvanchula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVanchula Srinivasan |
| Designation |
Post Doctoral Fellow - Neuroanaesthesiology |
| Affiliation |
Kauvery Institute of Brain and Spine, Kauvery Hospital,Radial Road |
| Address |
Department of Neuroanaesthesiology and Critical Care,
Kauvery Hospital,Radial Road,
Chennai.
Chennai
TAMIL NADU
600129
India |
| Phone |
9940672171 |
| Fax |
|
| Email |
drvanchula@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2/473, 200 feet Radial Road,
Ganapathy Nagar,
Kovilambakkam,
Chennai, |
|
Primary Sponsor
Modification(s)
|
| Name |
DrVanchula Srinivasan |
| Address |
Department of Neuroanaesthesiology and Neurocritical Care, Kauvery Hospital, Radial road, Chennai 129 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrPonniah Vanamoorthy |
Department of Neuroanaesthesiology and Neurocritical Care, Kauvery Hospital, Radial road, Chennai 129 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVanchula Srinivasan |
Kauvery Hospital, Radial Road |
6th floor
Neurocritical care unit,
Kauvery Institute of Brain and Spine.
Chennai
TAMIL NADU |
9940672171
drvanchula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kauvery Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of study drug/drugs |
Patients who meet the criteria for the study will be divided into two groups using a computer generated random table and administered the study drug/drugs.
|
| Comparator Agent |
Group 1 – will receive IV Ondansetron 8mg – within 30 minutes of end of the surgery.
|
Group 2 – will receive Oral Apprepitant – 80 mg – Pre operatively 3 hours prior to induction of anaesthesia and IV Ondansetron 8mg within 30 minutes of end of the surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Consenting patients
undergoing Elective Craniotomy surgeries,
under ASA grades 1 and 2.
|
|
| ExclusionCriteria |
| Details |
Non consenting patients
Pregnant patients
ASA grading 3 and above
Patients with known or suspected to have allergy for study drug
Emergency surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of IV ondansetron when given alone versus combination of IV ondansetron and Oral aprepitant in management of PONV in patients undergoing elective craniotomy surgeries. |
Incidence of PONV will be recorded at initial 0 to 2 hours, at 2 to 6 hours, 6 to 24 and 24 to 48 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess the incidence of PONV in patients undergoing elective craniotomy surgeries.
To assess timing and need for rescue anti-emetic and/ or repeat dosing of same drug in treating PONV. |
Incidence of PONV will be recorded at initial 0 to 2 hours, at 2 to 6 hours, 6 to 24 and 24 to 48 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvanchula@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Postoperative nausea and vomiting (PONV) is any nausea, vomiting, or retching in the post-anesthesia care unit during the 48-hour period following surgery.The incidence of PONV following Craniotomy is 22% to 70% without prophylaxis and even with prophylaxis the average incidence was 50%. ASA Guidelines recommend a multi-modal approach for prevention of PONV- combining different classes of antiemetic drugs with diverse mechanisms. Our study aims to compare- IV Ondansetron when used alone and in combination with Oral Apprepitant in patients undergoing elective craniotomy surgeries.
•ONDANSETRON – is a highly potent and selective antagonist at 5-HT3 receptors at two specific sites (i) centrally, in the area postrema/NTS; and (ii) peripherally on vagus nerve terminals. •APPREPITANT - is a highly selective competitive antagonist of the G-protein–coupled Neurokinin 1 Receptor (NK1) present in the (i) central pattern generator, the nucleus tractus solitarius, and the area postrema to attenuate the likelihood of initiating the complex vomiting reflex. (ii) Peripherally, NK-1Rs exist throughout the gastrointestinal tract. (iii) The binding of the aprepitant to NK-1Rs may attenuate vagal afferent signals, thereby contributing to the antiemetic effect. PRIMARY OBJECTIVE: •To assess the efficacy of IV ondansetron when given alone versus combination of IV ondansetron and Oral aprepitant in management of PONV in patients undergoing elective craniotomy surgeries. SECONDARY OBJECTIVE: •Assess the incidence of PONV in patients undergoing elective craniotomy surgeries. •To assess timing and need for rescue anti-emetic and/ or repeat dosing of same drug in treating PONV. |