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CTRI Number  CTRI/2025/12/098673 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 03/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To find the incidence of post-operative nausea and vomiting in patients undergoing cancer surgeries. 
Scientific Title of Study   Incidence of postoperative nausea and vomiting in patients undergoing oncosurgical anaesthesia: A single-center prospective observational study. 
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 Pavithra Dommaraju 
Designation  MBBS,Post graduation (MD)Anaesthesiology and critical care medicine 
Affiliation  Sri Venkateswara Institute of medical sciences (SVIMS) 
Address  Department of Anaesthesiology,SVIMS,Alipiri,Tirupati,Chittoor district,Andhra Pradesh,517507 India

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9703735962  
Fax    
Email  Pavithraraju496@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sri Devi R 
Designation  Associate Professor ,Department of Anaesthesiology and Critical care medicine,SVIMS 
Affiliation  Sri Venkateswara Institute of medical sciences (SVIMS) 
Address  Department of Anaesthesiology,SVIMS,Alipiri,Tirupati,Chittoor district,Andhra Pradesh,517507 India

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547661  
Fax    
Email  sridevi.radhapuram@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sri Devi R 
Designation  Associate Professor ,Department of Anaesthesiology and Critical care medicine,SVIMS 
Affiliation  Sri Venkateswara Institute of medical sciences (SVIMS) 
Address  Department of Anaesthesiology,SVIMS,Alipiri,Tirupati,Chittoor district,Andhra Pradesh,517507 India

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547661  
Fax    
Email  sridevi.radhapuram@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara Institute of Medical Sciences,Alipiri road,Tirupati,Chittoor,Andhra Pradesh 517507 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Pavithra Dommaraju  Sri Venkateswara Institute of Medical Sciences  Department of Anaesthesiology,SVIMS,Alipiri road,Tirupati Chittoor district Andhra Pradesh 517507
Chittoor
ANDHRA PRADESH 
09703735962

Pavithraraju496@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,SVIMS,Tirupati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)All the adult patient equal or above 18years will be considered for inclusion
2)Patients undergoing oncosurgeries under anaesthesia 
 
ExclusionCriteria 
Details  1)use of antiemetic drugs within 24 hours before surgery.
2)Patients receiving chemotherapy or radiotherapy within 7 days before surgery
3)Patients who did not recover from anaesthesia by the time of data collection
4)Patients who undergo re exploration within 24 hours postoperatively
5)Postoperative mechanical ventilation for more than 2 hours
6)Patients discharged within 24 hours of surgery
7)Patients with known gastrointestinal disorders(example-gastroesophageal reflux,gastric outlet obstruction)
8)Patients with a history of psychiatric illness that may affect nausea perception or reporting
9)Uncooperative patients or those unable to give consent
10)Patients who are pregnant or lactating 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the occurrence of Postoperative nausea and vomiting in patients undergoing oncological surgeries under anaesthesia  Assessments will be done at fixed time points :immediately on arrival to post anaesthetic unit and later 2,6,24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the association between perioperative variables and occurrence of post operative nausea and vomiting   For preoperative variables before the day of surgery.
For intraoperative variables at the time of surgery.
For postoperative variables on arrival to post anaesthetic care unit and later at 2,6,24 hours after surgery. 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
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)   16/12/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Pavithraraju496@gmail.com].

  6. For how long will this data be available start date provided 16-12-2025 and end date provided 16-12-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Postoperative nausea and vomiting(PONV) is a frequent and distressing complication after surgery, with an incidence ranging from 10–80% depending on patient factors, surgery type, and anaesthetic technique. Beyond discomfort, PONV can lead to complications like dehydration, electrolyte imbalance, aspiration, and wound dehiscence. These consequences delay recovery, increase healthcare costs, and reduce overall patient satisfaction.


Despite the availability of multiple antiemetic agents and preventive strategies, PONV continues to be challenging due to its multifactorial nature and different patient responses. Studies show that some patients avoid postoperative analgesics completely to prevent nausea, highlighting its significant physical burden to the patient .Such findings emphasize that nausea is more than just a symptom. Effective management is therefore essential for improved safety, comfort, and better surgical outcomes.


The mechanism of PONV involves complex interactions among serotonergic, dopaminergic, histaminergic, cholinergic, and neurokinin pathways. Established risk factors include female sex, younger age, non smoking status, opioid use, and prolonged anaesthesia. Common antiemetics include 5-HT3 antagonists, corticosteroids, and NK1 blockers, with ondansetron widely used for its safety and rapid onset. While multimodal prophylaxis is recommended for high-risk patients, single-agent therapy remains common in resource-limited settings.


PONV rates differ significantly across oncology surgeries, being especially high in gynecological, head-and-neck and neurosurgical cases . Orthognathic procedures also show elevated risk compared to minor oral surgeries. In India, limited observational research exists documenting the PONV incidence, particularly with ondansetron as a standalone prophylactic. Most studies focus on specific cancer types, creating a gap in comprehensive data across diverse oncology surgeries.


The aim of the present study is to determine the occurrence of PONV in patients undergoing oncological surgeries under anaesthesia. The primary objective is to assess the incidence of PONV within the first 24 hours postoperatively. The secondary objective is to evaluate associations between perioperative variables and the development of PONV. This will help identify high risk groups and guide more targeted preventive strategies.


All patients will undergo pre anaesthetic evaluation,  and have demographic and clinical risk variables recorded. Standard anaesthetic care with routine monitoring will be provided, and intraoperative variables such as type of surgery,type of anaesthesia ,type of iv fluids,amount of iv fluids,dosage of opioids ,input and output,duration of surgery will be documented. Postoperatively, patients will be assessed  

immediately on arrival to PACU and later at 2, 6, and 24 hours after surgery. Injection ondansetron  and injection dexamethasone  iv given according to body weight and will be used as the rescue antiemetics.Postoperative variables recorded include nausea scores using the 11-point Numeric Nausea Score,opioid use, vomiting episodes, and the need for rescue antiemetics and the patients response closely monitored.

 
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