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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  
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 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  
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 
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 .

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