| CTRI Number |
CTRI/2025/07/090470 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Apfel score prophylaxis versus Universal prophylaxis for post-operative nausea and vomiting |
|
Scientific Title of Study
|
To evaluate the effectiveness of Apfel score based prophylaxis versus Universal prophylaxis to reduce the need of antiemetic for post-operative nausea and vomiting in patients under general anaesthesia at SMS Medical College Jaipur |
| 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 Samridhi Nanda |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached hospital |
| Address |
Department of Anaesthesia, Second floor,OT Complex, Dhanwantari building,Sawai Man Singh Medical College and Attached Hospital.
Rajasthan
302004
India
Jaipur RAJASTHAN 302004 India |
| Phone |
9680565399 |
| Fax |
|
| Email |
samridhinanda@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Samridhi Nanda |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached hospital |
| Address |
Department of Anaesthesia, Second floor,OT Complex, Dhanwantari building,Sawai Man Singh Medical College and Attached Hospital.
Rajasthan
302004
India
Jaipur RAJASTHAN 302004 India |
| Phone |
9680565399 |
| Fax |
|
| Email |
samridhinanda@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vipin Kumar Yadav |
| Designation |
Resident doctor |
| Affiliation |
Sawai Man Singh Medical College and Attached hospital |
| Address |
Department of Anaesthesia, Second floor,OT Complex, Dhanwantari building,Sawai Man Singh Medical College and Attached Hospital.
Rajasthan
302004
India
Jaipur RAJASTHAN 302004 India |
| Phone |
8890396986 |
| Fax |
|
| Email |
dr.vipinyadav18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur,Pin code-302004, Rajasthan ,India |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur |
| Address |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Samridhi Nanda |
General Surgery OT ,SMS Medical College and Hospital Jaipur |
Department of Anaesthesia,Second floor,Dhanwantri building,
Sawai Man Singh Medical College and Attached Group of Hospitals,
Jaipur,
Rajasthan
302004 Jaipur RAJASTHAN |
09680565399
samridhinanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE ETHICS COMMITTEE, SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS, JAIPUR |
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 |
| Comparator Agent |
All patients posted for surgery under General anaesthesia were given Inj. Ondansetron 0.1mg/kg regardless of their APFEL score |
All patinets will receive PONV prophylaxis with intravenous ondansetron 0.1mg/kg once, , administered 30 minutes before the expected completion of surgery.All patients will be followed up at the end of 24 hours for any episodes of PONV and requirement of antiemetics |
| Intervention |
Assessing the risk for PONV preoperatively through APFEL score |
Only patients with moderate (score 2)and high (scores 3,4) risk according to the Apfel score will receive PONV prophylaxis with Intravenous Injection ondansetron 0.1mg/kg, administered once 30 minutes before the expected completion of surgery. Low risk patients (scores 0,1) will receive no prophylaxis. All patients will be followed up at the end of 24 hours for any episodes of postoperative nausea & vomiting |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient schedule for various elective surgery under general anaesthesia required endotracheal intubation.
2 Patient willing to give written informed consent.
3.Body mass index less than 30kg/m2.
4.American society of anaesthesiologist (ASA) class 1 and 2.
|
|
| ExclusionCriteria |
| Details |
1.Patient required post operative mechanical ventilation .
2.Patient with known allergy to ondansetron.
3.Patient in whom metoclopramide has been used for aspiration prophylaxis. |
|
|
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 |
1.To assess and compare the number of patient having post operative nausea and vomiting (PONV) between the two groups.
2.To assess and compare the dose of rescue antiemetic (inj.metaclopramide10mgiv,inj dexamethasone0.2mg/kg iv) required in first 24 Hours post operatively between the two groups |
1.Episodes of Nausea and vomiting at the end of 24 hours after the surgery.
2. Number of doses of anti emetic given at the end of 24 hours after the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the difference in proportion of patient having side effects (palpitations, constipation, headache etc.)if between two groups |
At the end of 24 hours after the surgery . |
|
|
Target Sample Size
|
Total Sample Size="420" Sample Size from India="420"
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)
|
01/09/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Post-operative nausea
and vomiting (PONV) is a common and distressing complication that significantly
impacts patient well-being, particularly within the first 24 hours following
surgery.
The primary goal of
prophylactic measures against PONV is to reduce its occurrence, thereby
enhancing the overall quality of patient care and facilitating smoother
recovery processes. To address this issue, various
predictive scoring systems have been developed to identify patients at higher
risk of developing PONV, enabling more targeted prophylactic intervention.
Among the most notable of these systems are
those introduced by Apfel et al. in Germany and Koivuranta
et al in Finland. These systems utilize specific risk
factors to stratify patients according to their likelihood of experiencing
PONV, thereby allowing clinicians to tailor prophylactic treatments to those
most likely to benefit .
The Apfel scoring
system, in particular, has gained widespread acceptance and is frequently used
in clinical settings. This system evaluates patients based on factors such as
gender, history of motion sickness or PONV, non-smoking status, and the use of
postoperative opioids, assigning a score that correlates with the patient’s
risk level.
With this background, we plan to
conduct this study to evaluate the effectiveness of Apfel score based
prophylaxis versus universal prophylaxis to reduce the need of antiemetic for
post operative nausea and vomiting in patients under general anaesthesia .
. |