| 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
|
|
|
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
|
|
|
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
- 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 Response - Clinical Study Report Response - Analytic Code Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Pavithraraju496@gmail.com].
- 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.
- 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. |