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
|
|
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
|
|
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. |