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CTRI Number  CTRI/2023/06/054092 [Registered on: 19/06/2023] Trial Registered Prospectively
Last Modified On: 19/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to compare how good oral disintergrating film of ondansetron versus intravenous ondansetron is in the prevention of postoperative nausea and vomiting in patients undergoing oocyte retrieval procedure under intravenous sedation. 
Scientific Title of Study   Comparing the efficacy of oral disintergrating film versus intravenous ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing oocyte retrieval procedure under intravenous sedation(propofol based) : double blind, randomised academic trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajmal Muhammed 
Designation  Post graduate 
Affiliation  Yenepoya Medical College 
Address  602, A-Block, Gardenia Hostel, University Road, Deralakatte, Mangaluru, Karnataka
Department of Anaesthesiology, Yenepoya Medical College, University Road, Deralakatte, Mangaluru, Karnataka - 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9995466986  
Fax    
Email  dr.ajmalmuhammed@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Krishna Prasad P 
Designation  Associate Professor 
Affiliation  Yenepoya Medical College 
Address  Department of Anaesthesiology, Yenepoya Medical College, University Road, Deralakatte, Mangaluru, Karnataka - 575018
Department of Anaesthesiology, Yenepoya Medical College, University Road, Deralakatte, Mangaluru, Karnataka - 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9844774108  
Fax    
Email  hidrkp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajmal Muhammed 
Designation  Post graduate 
Affiliation  Yenepoya Medical College 
Address  602, A-Block, Gardenia Hostel, University Road, Deralakatte, Mangaluru, Karnataka
Department of Anaesthesiology, Yenepoya Medical College, University Road, Deralakatte, Mangaluru, Karnataka - 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9995466986  
Fax    
Email  dr.ajmalmuhammed@gmail.com  
 
Source of Monetary or Material Support  
YENEPOYA MEDICAL COLLEGE, University road, Deralakatte, Mangaluru, Karnataka-575018 
 
Primary Sponsor  
Name  Yenepoya Medical College 
Address  Yenepoya Medical College, University Road, Deralakatte, Mangaluru, Karnataka - 575018 
Type of Sponsor  Private 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 
Ajmal Muhammed  Yenepoya Medical College  Department of Anaesthesiology, Yenepoya Medical College, University Road, Deralakatte, Mangaluru, Karnataka - 575018
Dakshina Kannada
KARNATAKA 
9995466986

dr.ajmalmuhammed@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee-1  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  Intravenous ondanseteron   Intravenous ondansetron (4 mg diluted to 10 ml with 0.9% normal saline) given over 5 minutes, preoperatively, for prevention of postoperative nausea and vomiting following oocyte retreival under intravenous sedation.  
Intervention  Oral disintegrating film (ODF) of ondansetron   Oral disintegrating film of ondansetron 8 mg given preoperatively, for prevention of postoperative nausea and vomiting following oocyte retreival under intravenous sedation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  American society of Anaesthesiologists (ASA) PS I & II .
Age- females in reproductive age group (Age-18-40 years).
BMI less than 30.
Infertility
Ovum Pickup
Procedures lasting upto 60 minutes duration.
Daycare procedure / admission.
 
 
ExclusionCriteria 
Details  ASA PS â…¢ & above
Participants with cardiac rhythm abnormalities
BMI > 30
H/o seizures and neurological deficits
Participants with severe respiratory, cardiovascular, renal and hepatic diseases
Participants with prior history of PONV or anti-emetic therapy pre-operatively
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure the efficacy of the oral disintegrating film of ondansetron in the prevention of Postoperative nausea and vomiting.
 
6 hours or till discharge of daycare patient. 
 
Secondary Outcome  
Outcome  TimePoints 
Measure time for rescue anti-emetic, Side effects, if any.  1 year 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   22/06/2023 
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="2"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After approval from the Institutional Ethics Committee, written informed consent will be obtained from female participants in reproductive age group with ASA physical status â…  and â…¡ who will be posted for oocyte retrieval procedure under intravenous sedation (propofol based).Participants will be in randomised into two groups by simple randomisation, Participants allotted in each group by lottery method, A and B, with 42 participants in each group.

Group A will receive intravenous ondansetron (4 mg).Group B will receive (ODF) of ondansetron (8 mg).Thorough detailed medical history and physical examination will be obtained and co morbidities, if any will be noted. Nil per oral (NPO) status will be confirmed. Participants will be randomised into group A and group B. Ondansetron ODF formulation which is administered in the preoperative room 30 min before procedure. ODF is formulation which disintegrates within 5 sec in mouth when placed on tongue. Given preoperatively to prevent PONV .

In the operating room, i.v. access will be secured and standard ASA monitors [Electrocardiogram (ECG), pulse oximeter (SpO2) and noninvasive blood pressure (NIBP)] will be attached. Group A will receive i.v. ondansetron (4 mg diluted to 10 ml with 0.9% normal saline) given over 5 minutes and placebo ODF. Group B will receive ODF ondansetron and 10 ml 0.9% normal saline given over 5 minutes. Anaesthesia will be standardised. Premedication with Inj. midazolam 1 mg will be administered. Analgesia will be provided by Inj. fentanyl 1mcg/kg. Anaesthesia will be induced with Inj. propofol 1 mg/kg and maintained on propofol infusion in the dose of 3 mg/kg/hr. Patients will be ventilated with oxygen through face mask @6-8 L/min to maintain a SpO2 of more than 95%. Patients will maintained on spontaneous ventilation. At the end of procedure all patients will receive paracetamol 250 mg suppository.


Postoperatively, all patients will be monitored for a minimum of 2 hours in the PACU and kept nil per oral for 4 hours. PONV will be assessed every hour for 6 hours or till discharge whichever is earlier. The parameters will be recorded on the proforma and tabulated in the master chart preoperatively. Main benefit is cost effectiveness and more convienient to use. Free hospitalisation and medication will be provided in case of any adverse effects. Rescue anti emetic drug given -Dexamethasone 4-8mg intravenous if participant experience PONV.

 
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