| CTRI Number |
CTRI/2026/01/101436 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing three medicines used for preventing post operative nausea and vomiting in patients undergoing craniotomy surgeries |
|
Scientific Title of Study
|
Comparision of efficacy of ondansetron versus palanosetron versus ramosetron for prevention of post operative nausea and vomiting (PONV) in elective craniotomy surgeries- A randomized double blinded prospective study |
| Trial Acronym |
PONV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASHWITHA VAIDYA |
| Designation |
POST GRADUATE |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
NIIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA
Hyderabad TELANGANA 500082 India |
| Phone |
9542419135 |
| Fax |
|
| Email |
ASHWITHAVAIDYA97@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
DR ASHWITHA VAIDYA |
| Designation |
POST GRADUATE |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
NIIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA
Hyderabad TELANGANA 500082 India |
| Phone |
9542419135 |
| Fax |
|
| Email |
ASHWITHAVAIDYA97@GMAIL.COM |
|
Details of Contact Person Public Query
|
| Name |
DR ASHWITHA VAIDYA |
| Designation |
POST GRADUATE |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
NIIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA
Hyderabad TELANGANA 500082 India |
| Phone |
9542419135 |
| Fax |
|
| Email |
ASHWITHAVAIDYA97@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ASHWITHA VAIDYA |
| Address |
NIZAMS INSTITUTE OF MEDICAL SCIENCES (NIMS), PUNJAGUTTA |
| Type of Sponsor |
Other [Self] |
|
|
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 Vaidya Ashwitha |
Nizams Institute Of Medical sciences (NIMS) |
Department of Anaesthesiology,
First Floor, Old building,
Nizams Institute of Medical Sciences (NIMS), Punjagutta Hyderabad TELANGANA |
9542419135
ashwithavaidya97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C7A8||Other malignant neuroendocrine tumors, (2) ICD-10 Condition: C7A8||Other malignant neuroendocrine tumors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ONDANSETRON |
1st generation 5HT3 receptor antagonist, dose - 0.15mg/kg,administered at the time of dura closure, duration of action 12hours |
| Intervention |
PALONOSETRON |
2nd generation 5HT3 receptor antagonist, Dose - 1mcg/kg, intravenous, at the time of closure of dura, duration of action - more than 24 hours |
| Intervention |
RAMOSETRON |
2nd generation 5HT3 receptor antagonist, dose -6mcg/kg, intravenous, at the time of closure of dura, duration of action -24 hours |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA PHYSICAL STATUS 1, 2
UNDERGOING ELECTIVE CRANIOTOMY SURGERIES |
|
| ExclusionCriteria |
| Details |
Patients aged less than 19 and more than 65, belonging to ASA class 3 or more, patients having gastric diseases,history of vomiting, history of craniotomy,on antibiotics cancer chemotherapy, anti emetic use within 24hours, severe renal or hepatic insufficiency,borderline QT prolongation, chronic use of opioids ,on antidepressant medication, undergoing emergency surgeries with poor GCS , who could not communicate,pregnant |
|
|
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 |
| To evaluate and compare for the incidence of complete response ( no nausea, no vomiting, no use of rescue medication) |
In first 48 hours between three groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare for the incidence of vomiting, retching, nausea ( intensity/ severity) |
0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS POSTOPERATIVELY |
| To compare side effects profile between three groups |
0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS POSTOPERATIVELY |
| To look for the need for rescue anti emetic |
0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS |
| To evaluate patient satisfaction using Likert scale between three groups |
48 HOURS POSTOPERATIVELY |
|
|
Target Sample Size
|
Total Sample Size="162" Sample Size from India="162"
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 2 |
|
Date of First Enrollment (India)
|
28/01/2026 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
PONV referred to as the big little problem or the little big problem after surgery or anaesthesia is one of the most common perioperative concerns with a relatively high incidence of up to 73 percent after craniotomy The incidence of PONV reaches 25 to 30 percent often rising to 80 percent after general anaesthesia among patients without prophylactic intervention PONV in neurosurgical patients causes pain tachycardia aspiration patient discomfort intravascular volume depletion dehydration acid base disturbances and elecrolyte imbalances like symptomatic hyponatremia hypokalemia hypochloremia it may also lead to increase in intracranial pressure and wound dehiscence hematoma which may be deleterious to the patients therefore it is imperative that PONV be managed optimally for after elective craniotomy because effective treatments to prevent or manage post operative nausea and vomiting allow early mobilization early food intake and improve overall patient satisfaction it is of even more importance in neurosurgical patients as even mild to moderate PONV may raise confusion regarding features of raised intracranial pressure in the postoperative period severe pharmacological interventions including anticholinergics antihistamines corticosteroids dopamine receptor antagonists and serotonin receptor antagonists for treating and preventing PONV have been assesed the lack of sedative effects makes 5HT3 antagonists the gold standard drugs for PONV prophylaxis in craniotomies when postoperative clinical neurological assesments are required To the best of our knowledge there are no studies that have evaluated and compared the antiemetic efficacy of ondansetron palonosetron and ramosetron after elective craniotomy Therefore we have undertaken this study and hypothesized that palonosetron and ramosetron would provide a greater clinical benifit than ondansetron in this surgical cohort |