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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  
NIL 
 
Primary Sponsor  
Name  DR ASHWITHA VAIDYA 
Address  NIZAMS INSTITUTE OF MEDICAL SCIENCES (NIMS), PUNJAGUTTA 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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