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CTRI Number  CTRI/2022/10/046372 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Aprepitant and dexamethasone in prevention of nausea and vomiting after laparoscopic cholecystectomy  
Scientific Title of Study   Comparison of the effects of Aprepitant and Dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy: A double blind randomised trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Wasimul Hoda 
Designation  Assistant Professor, Department of Anaesthesiology 
Affiliation  Assistant Professor, Department of Anaesthesiology, Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences

Ranchi
JHARKHAND
834009
India 
Phone  8797770602  
Fax    
Email  wasu077@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  WASIMUL HODA 
Designation  Assistant Professor, Department of Anesthesiology, 
Affiliation  Assistant Professor, Department of Anesthesiology, Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences

Ranchi
JHARKHAND
834009
India 
Phone  8797770602  
Fax    
Email  wasu077@gmail.com  
 
Details of Contact Person
Public Query
 
Name  WASIMUL HODA 
Designation  Assistant Professor 
Affiliation  Assistant Professor, Department of Anaesthesiology, Rajendra Institute of Medical Sciences 
Address  DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES

Ranchi
JHARKHAND
834009
India 
Phone  8797770602  
Fax    
Email  wasu077@gmail.com  
 
Source of Monetary or Material Support  
INTRAMURAL PROJECT FUNDED BY RESEARCH CELL OF RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  Intramural project funded by Research cell of Rajendra Institute Of Medical Sciences 
Address  Rajendra Institute Of Medical Sciences, Bariatu 834009, Ranchi Jharkhand 
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 
WASIMUL HODA   Department of Anaesthesia, Rajendra Institute of Medical Sciences  RAJENDRA INSTITUTE OF MEDICAL SCIENCES, BARIATU, RANCHI 834009, JHARKHAND
Ranchi
JHARKHAND 
8797770602

wasu077@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICAL COMMITTE, RIMS RANCHI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  APREPITANT   PATIENT IN GROUP I WILL RECEIVE 80 MG ORAL APREPITANT 3 HOURS BEFORE INDUCTION OF ANAESTHESIA  
Comparator Agent  DEXAMETHASONE   PATIENTS IN GROUP II WILL RECEIVE 8 MG DEXAMETHASONE INTRAVENOUSLY AT THE TIME OF INDUCTION OF ANAESTHESIA  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA GRADE I & II PATIENTS SCHEDULED FOR ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY SURGERY 
 
ExclusionCriteria 
Details  PATIENTS WHO HAD A HISTORY OF DRUG ABUSE, HYPERSENSITIVITY REACTION, NAUSEA AND RECEIVED ANTIEMETIC BEFORE SURGERY WITHIN 24 HOURS, PREGNANCY, BREASTFEEDING STATUS  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy variable will be episodes of nausea and vomiting in the early and late postoperative period in first 24 hours.
 
first 24 hours after surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 

The incidence of any adverse reaction to treatment in the two experimental groups will be recorded
 
24 hours 
 
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)   01/11/2022 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT STARTED 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Postoperative nausea and vomiting (PONV) is one of the most common postsurgical complications (Myles et al. 2000). It is caused by various factors such as the use of anaesthetics, perioperative use of opioids, the type of surgery, and patient characteristics (Apfel et al. 2003). PONV decreases overall patient satisfaction and is associated with poor surgical outcomes. It extends the hospitalisation period because of delayed recovery and causes fatal complications such as suture laceration, bleeding, increased intracranial pressure, aspiration pneumonia, dehydration and electrolyte imbalance (Gan et al. 2003).

Various classes of medications, including serotonin receptor antagonists and dopamine receptor antagonists are currently used to prevent PONV in patients undergoing laparoscopic cholecystectomy. However, due to increased intra-abdominal pressure during laparoscopy and perioperative use opioids, the risk of PONV increases (Bradshaw et al . 2002). Even after the use of recommended drugs for PONV prophylaxis, patient experiences significant amount of postoperative nausea and vomiting after laparoscopic cholecystectomy.

Aprepitant is a neurokinin-1 receptor antagonist that blocks the emetic effects of substance P (SP) at neurokinin-1 receptors in the gastrointestinal tract. It also inhibits the signals received from the chemoreceptor trigger zone by the nucleus tractus solitarius in the brain stem (Diemunsch et al. 2009). Aprepitant has been used to prevent chemotherapy-induced nausea and vomiting. However, its efficacy in PONV prevention in non-chemotherapy patients and elective surgeries is still unexplored.

 

In previous literatures, the evidences for analgesic property of Aprepitant are few and lacking. Therefore, our hypothesis of considering Aprepitant a better alternative for PONV prevention and pain control can change our practice in anaesthesia. Aprepitant may become a part of multimodal analgesia with additional antiemetic property leading to better patient satisfaction and early discharge. 

 

However, Dexamethasone is well known for its antiemtic and analgesic properties, its comparison with Aprepitant can bring up new evidences for PONV prevention and pain management in patients undergoing laparoscopic cholecystectomy. 

 
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