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CTRI Number  CTRI/2023/01/049005 [Registered on: 13/01/2023] Trial Registered Prospectively
Last Modified On: 08/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of 3 medicine and 2 medicines for prevention of vomiting after surgery. 
Scientific Title of Study   Comparison of Aprepitant, Dexamethasone and Ondansetron with Dexamethasone and Ondansetron for prevention of post operative nausea vomiting in high risk patients undergoing laparoscopic surgeries. 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  Shalini Bala 
Designation  Junior Resident 
Affiliation  AIIMS JODHPUR 
Address  AICU Department of Anaesthesiology and Critical care, 3rd floor, D and T Block, AIIMS Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9789577143  
Fax    
Email  shalinibala28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pradeep Bhatia 
Designation  Professor And Head of Department 
Affiliation  AIIMS JODHPUR 
Address  AICU Department of Anaesthesiology and Critical care, 3rd floor, D and T Block, AIIMS Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9829159665  
Fax    
Email  pk_bhatia@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Shalini Bala 
Designation  Junior Resident 
Affiliation  AIIMS Jodhpur 
Address  AICU Department of Anaesthesiology and Critical care, 3rd floor, D and T Block, AIIMS Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9789577143  
Fax    
Email  shalinibala28@gmail.com  
 
Source of Monetary or Material Support  
AIIMS,Jodhpur 
 
Primary Sponsor  
Name  AIIMS 
Address  AIIMS JODHPUR 
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 
SHALINI BALA  All India Institute of Medical Sciences  2A ward 2nd Floor IPD block AIIMS Jodhpur
Jodhpur
RAJASTHAN 
9789577143

shalinibala28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE AIIMS JODHPUR  Approved 
INSTITUTIONAL ETHICS COMMITTEE AIIMS JODHPUR  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  Aprepitant  Adding Tab Aprepitant 80mg Orally 2 Hours Prior to Surgery to Inj Dexamethasone 8mg IV given at Induction and Inj Ondansetron 4 mg Given prior to Extubation as Prophylaxis in Patients with High risk for Post Operative Nausea and Vomiting.  
Comparator Agent  Placebo  Adding Placebo Tablet Orally 2 Hours Prior to Surgery to Inj Dexamethasone 8mg IV given at Induction and Inj Ondansetron 4 mg Given prior to Extubation as Prophylaxis in Patients with High risk for Post Operative Nausea and Vomiting. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  FEMALE >18 YRS,NON SMOKERS UNDERGOING LAPAROSCOPIC SURGERY LASTING 2-4 HOURS, RECEIVING INTRAOPERATIVE AND POSTOPERATIVE OPIOID ANALGESIA. 
 
ExclusionCriteria 
Details  1. CONSUMPTION OF AN AGENT WITH ANTI EMETIC PROPERTIES WITHIN 24 HRS PRIOR TO COMMENCEMENT OF THE STUDY.
2. KNOWN HYPERSENSITIVITY TO APREPITANT, ONDANSETRON OR DEXAMETHASONE.
3. PREGNANCY.
4. PATIENTS REQUIRING POSTOPERATIVE MECHANICAL VENTILATION.
5. SURGERY LASTING >4 HRS
6. TIVA
7. PATIENTS NOT GIVING CONSENT. 
 
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 
TO COMPARE THE INCIDENCE OF POSTOPERATIVE NAUSEA AND VOMITING.  2 HOURS AND 24 HOURS FOLLOWING SURGERY. 
 
Secondary Outcome  
Outcome  TimePoints 
TIME TO FIRST RESCUE ANTIEMETIC AND THE AMOUNT OF ANTIEMETIC CONSUMED.  FIRST 24 HOURS. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   18/01/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT APPLICABLE 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

POST-OPERATIVE NAUSEA VOMITING OCCUR IN UPTO 30% OF ALL SURGICAL PATIENTS 70 - 80% OF HIGH RISK PATIENTS FOLLOWING SURGERY WITH NO PROPHYLACTIC ANTIEMETIC THERAPY. PONV CAN RESULT IN NUMEROUS ADVERSE EVENTS INCLUDING FLUID IMBALANCES, WOUND DEHISCENCE, ESOPHAGEAL TEARS AND RAISED INTRACRANIAL PRESSURE. IT INCREASES PATIENTS DISCOMFORT AS WELL AS DELAYS RECOVERY AND DISCHARGE RESULTING IN INCREASED HEALTH CARE COSTS. FEMALE SEX, YOUNGER AGE, NON SMOKING STATUS, POST-OPERATIVE OPOID ANALGESIA AND HISTORY OF MOTION SICKNESS ARE RISK FACTORS FOR PONV. THIS STUDY AIMS AT COMPARING THE INCIDENCES OF PONV AFTER TRIPLE DRUG PROPHYLAXIS (GROUP A) WITH APREPITANT 80MG, DEXAMETHASONE 8MG AND ONDANSETRON 4MG AS COMPARED TO THE ROUTINELY USED PROPHYLAXIS (GROUP C) WITH 8MG DEXAMETHASONE AND 4MG ONDANSETRON. FEMALES >18YRS, NON SMOKERS UNDERGOING LAPAROSCOPIC SURGERY LASTING 2-4 HOURS, RECEIVING INTRAOPERATIVE AND POSTOPERATIVE OPOID ANALGESIA WILL BE GIVEN APREPITANT 80MG IN GROUP A  ( 82 PARTICIPANTS) AND  PLACEBO IN GROUP C (82 PARTICIPANTS) 2HRS BEFORE THE SURGERY. PATIENTS WILL BE FOLLOWED UP AT TWO POINTS- 2HRS AND 24HRS AFTER SURGERY FOR THE INCIDENCE OF NAUSEA AND VOMITING (PRIMARY OUTCOME). THE SECONDARY OUTCOME WILL BE THE TIME TO FIRST RESCUE ANTIEMETIC AND AMOUNT CONSUMED IN FIRST 24 HOURS. TO QUANTIFY SYMPTOMS A PONV SCALE WILL BE USED. A PONV IMPACT SCALE SCORE OF MORE THAN OR EQUAL TO 5 WILL BE CONSIDERED CLINICALLY IMPORTANT PONV.

 
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