| CTRI Number |
CTRI/2024/12/077677 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Palonosetron vs Palonosetron And Dexamethasone In Reducing Postoperative Nausea And Vomiting After Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
Comparison Of Palonosetron Versus Palonosetron With Dexamethasone In Prevention Of Postoperative Nausea And Vomiting After laparoscopic Cholecystectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kondamuru Likhitha |
| Designation |
Junior Resident |
| Affiliation |
Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation |
| Address |
Department of Anesthesiology, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation, Chinnaoutapalli
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9848724267 |
| Fax |
|
| Email |
likhithalovely27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr USSA Vara Prasad |
| Designation |
Professor and HOD, Department of Anaesthesiology |
| Affiliation |
Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation |
| Address |
Department of Anesthesiology, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation, Chinnaoutapalli
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9849725560 |
| Fax |
|
| Email |
doctorvaraprasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr USSA Vara Prasad |
| Designation |
Professor and HOD, Department of Anaesthesiology |
| Affiliation |
Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation |
| Address |
Department of Anesthesiology, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation, Chinnaoutapalli
ANDHRA PRADESH
521286
India |
| Phone |
9849725560 |
| Fax |
|
| Email |
doctorvaraprasad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Kondamuru Likhitha, Department of Anesthesiology, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation, Chinnaoutapalli, 521286, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Kondamuru Likhitha |
| Address |
Department of Anesthesiology, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation, Chinnaoutapalli, 521286, Andhra Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Kondamaru Likhitha |
Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation |
Department of Anaesthesiology, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation
Krishna
ANDHRA PRADESH |
9848724267
likhithalovely27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation |
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 |
| Comparator Agent |
Palonsetron and dexamethasone injection |
single dose of Palonsetron and dexamethasone injection to check postoperative nausea and vomiting |
| Intervention |
Palonsetron injection |
single dose of Palonsetron injection and check postoperative nausea and vomiting |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist Grade 1 & 2
Age between 18 and 60 years
Patients posted for laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
not willing to give consent
age less than 18 yrs and more than 60yrs
history of allergy to palonsetron and dexamethasone
electrolyte abnormalities
patient with drug history of SSRI and drugs which cause QT prolongation. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objectives of this study is to assess the efficacy of monotherapy(palonosetron) vs combination therapy(palonosetron – dexamethasone) in preventing postoperative nausea and vomiting |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objective is to study the number of rescue doses of antiemetics needed. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
◠Post-operative nausea and vomiting (PONV) is the second most common complaint in post-operative period after pain. ◠Although nausea and vomiting in post-operative period was reported to occur in 20%–30% of all laparoscopic surgeries and especially laparoscopic cholecystectomy significantly increases the incidence of PONV to as high as 50%. ◠Palonosetron is a second-generation 5-HT3 receptor antagonist having greater receptor binding affinity with a half-life of 40 h ◠Most of the literature and recent guidelines favours the use of dexamethasone and palonosetron, some studies differ in opinion. In this context, we hypothesised that the combination of palonosetron and dexamethasone will be better antiemetic for PONV prophylaxis than the individual medication and this study was planned to accept or reject that hypothesis. |