| CTRI Number |
CTRI/2024/09/073589 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two antiemetic drugs for the prevention of post operative nausea and
vomiting in neurosurgey patients |
|
Scientific Title of Study
|
Comparison Of Intravenous Amisulpride With Intravenous Ondansetron In The Prophylaxis Of Postoperative Nausea And Vomiting In Patients Undergoing Craniotomy For Supratentorial Tumour Surgery: A 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 Ajay Prasad Hirshi |
| Designation |
Additional Professor |
| Affiliation |
Sree Chitra Thirunal Institute of Medical Sciences and Technology, |
| Address |
Department of Neuroanesthesia,Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7012581920 |
| Fax |
|
| Email |
drajay@sctimst.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sreeja R |
| Designation |
Senior resident |
| Affiliation |
Sree Chitra Thirunal Institute of Medical Sciences and Technology |
| Address |
Department of Neuroanesthesia, Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496833742 |
| Fax |
|
| Email |
drsreeajith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreeja R |
| Designation |
Senior resident |
| Affiliation |
Sree Chitra Thirunal Institute of Medical Sciences and Technology |
| Address |
Department of Neuroanesthesia, Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496833742 |
| Fax |
|
| Email |
drsreeajith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Thirunal Institute of Science and Technology , Division of academic affairs, Room number- 4 Thiruvananthapuram, Kerala, India - 695011 |
|
|
Primary Sponsor
|
| Name |
Academic session Sree Chitra Thirunal Institute of Science and Technology |
| Address |
Sree Chitra Thirunal Institute of Science and Technology ,Thiruvanthapuram Kerala, India 695011 |
| 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 |
| Dr Sreeja R |
Sree Chitra Thirunal Institute of Medical sciences and Technology, |
Neurosurgery operation theatre and intensive care unit, division of neuroanesthesia, , fourth floor,room number 21
Thiruvananthapuram
KERALA |
9496833742
drsreeajith@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe, Sree Chitra thirunal Institute of medical sciences and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C710||Malignant neoplasm of cerebrum, except lobes and ventricles, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amisulpride |
Injection amisulpride 4mg is given at the end of the surgery to prevent post operative nausea and vomiting. Monitored for first 24 hours. |
| Comparator Agent |
Injection ondansetron |
Injection ondansetron 4mg will be given at the end of the surgery for prevention of nausea and vomiting. One more dose (4mg) will be given if the patient complains of naisea and vomiting. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult patients undergoing supratentorial craniotomy for tumour. |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)Patients with history of drug or alcohol abuse
3)History of nausea or vomiting
4)Pregnant or lactating women
5)Chemotherapy or radiation therapy during the previous 1month
6)Planned for postoperative ventilation |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of amisulpride vs ondansetron in prevention of post operative nausea and vomiting during the first 24 hours in patients undergoing craniotomy for supratentorial tumor. |
1 year for the recruitment
1 month for data analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the severity of nausea, use of rescue medications, postoperative pain and analgesic requirement, and incidences of adverse events in the first 24 hours postoperatively, in patients receiving amisulpride and ondansetron who are undergoing craniotomy for supratentorial tumor. |
1 year for the recruitment
1 month for data analysis |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
02/10/2024 |
| 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="1"
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
|
We plan to conduct a prospective randomised controlled trial to compare intravenous amisulpride with intravenous ondansetron in the prevention of postoperative nausea and vomiting in patients undergoing elective craniotomy for supratentorial tumour decompression.
|