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
|
|
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
|
|
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. |