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CTRI Number  CTRI/2024/08/072352 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Conservative strategy for preventing nausea and vomiting after surgery in low-risk patients  
Scientific Title of Study   Efficacy of a restrictive anti-emetic strategy in patients with low risk of postoperative nausea and vomiting (PONV)- A randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR CHAITRA V 
Designation  Assistant Professor 
Affiliation  Dr Chandramma Dayanand Sagar Institute of Medical Science & Research 
Address  CDSIMER Department of Anaesthesia Harohalli Ramanagar

Bangalore Rural
KARNATAKA
562112
India 
Phone  9113518096  
Fax    
Email  chaitra1591@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR CHAITRA V 
Designation  Assistant Professor 
Affiliation  Dr Chandramma Dayanand Sagar Institute of Medical Science & Research 
Address  CDSIMER Department of Anaesthesia Harohalli Ramanagar

Bangalore Rural
KARNATAKA
562112
India 
Phone  9113518096  
Fax    
Email  chaitra1591@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR CHAITRA V 
Designation  Assistant Professor 
Affiliation  Dr Chandramma Dayanand Sagar Institute of Medical Science & Research 
Address  CDSIMER Department of Anaesthesia Harohalli Ramanagar

Bangalore Rural
KARNATAKA
562112
India 
Phone  9113518096  
Fax    
Email  chaitra1591@gmail.com  
 
Source of Monetary or Material Support  
Dr chandramma Dayanand Sagar Institute of Medical Education and Research , Devarakaggalahalli, Harohalli, Kanakapura Road, Karnataka - 562112 
 
Primary Sponsor  
Name  Dr Chandramma Dayananda Sagar Institute of Medical Education and Research  
Address  Devarakaggalahalli,Harohalli, Ramanagar, Kanakapura Road-562112 
Type of Sponsor  Research institution and hospital 
 
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 Chaitra V  Dr Chandramma Dayananda Sagar Institue of Medical Education and Research   Department of Anesthesiology , Pre- operative room
Bangalore Rural
KARNATAKA 
9113518096

chaitra1591@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CDSIMER-IEC  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  ondansetron 4mg IV  ondansetron 4mg IV 
Comparator Agent  Inj ondansetron and Inj Dexamethasone  Inj ondansetron 4mg IV and Inj Dexamethasone 8 mg IV is compared with Inj ondansetron 4 mg IV prophylactically 30mins prior to surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. patients with APFEL score 2or less preoperatively
2. duration of surgery less than 60 minutes
3. surgeries under spinal/regional/ local anaesthesia 
 
ExclusionCriteria 
Details  surgeries with high risk of PONV like middle ear surgeries, laparotomy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of PONV in both groups in first 24 hours after surgery.  1) patients will be monitored for 24 hrs after surgery .
2)duration of study is 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Need for rescue antiemetics in 24 hours   1) patients will be monitored for 24 hrs after surgery .
2)duration of study is 1 year 
 
Target Sample Size   Total Sample Size="640"
Sample Size from India="640" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   26/08/2024 
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 - NO
Brief Summary  

 

Nausea and vomiting are one of the most frequently encountered symptoms in patients who have undergone a surgery.They can be especially distressing to the patient and hamper a speedy recovery, more so in case of day care procedures.  Post operative Nausea and Vomiting or PONV as it is frequently referred to as, is a very important factor in the overall patient satisfaction in the hospital.The estimated incidence of PONV is around 30% in the overall surgical population and can be as high as 80% in high risk cohorts.The occurrence of PONV is also associated with increased length of PACU stay and increased health care costs.Hence, reducing the incidence of PONV should be a constant strife for the anaesthesiologist.

 

The risk factors for an increased risk of PONV can be classified as patient factors like female sex, young age, non -smokers and a history of motion sickness/PONV and procedural factors like duration of anaesthesia, use of inhalational anaesthetics and nitrous oxide, General anaesthesia and use of post operative opioids.

 

Apfel and colleagues devised a scoring system to risk stratify patients as high or low risk for PONV. The ‘Apfel Score’ includes female gender, non-smoker, history of PONV or motion sickness and post operative use of opioids, with a higher score meaning a higher chance of the patient experiencing PONV. Koivuranta score includes the risk factors of Apfel score along with duration of surgery > 60 minutes.

 

The fourth consensus guidelines for the prevention and management of PONV was published in 2020 under the auspices of the American Society of Enhanced Recovery and Society for Ambulatory Anaesthesia. This is a comprehensive document for a clinician to practice in the perioperative arena. As per the consensus guidelines a multimodal therapy is advocated in patients to prevent PONV, with two different classes of anti-emetics in low risk and three or more different classes of anti-emetics in case of high risk patients. 

 

According to the fourth consensus guidelines for the management of PONV ‘there are very few studies directly comparing the efficacy of a risk-based “restrictive” antiemetic prophylaxis approach to a more liberal multimodal antiemetic prophylaxis approach’

They also state that direct comparisons of different combination therapies of anti-emetics is lacking and any evidence in that regard would prove invaluable.

 

 
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