| CTRI Number |
CTRI/2023/08/056860 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
23/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two groups of drugs for prevention of nausea & vomiting in women after surgery on uterus or ovaries. |
|
Scientific Title of Study
|
Combination of haloperidol & ondansetron is non inferior to dexamethasone & ondansetron for prevention of post operative nausea and vomiting in patients
undergoing laparoscopic gynaecological procedures. A randomised double blinded trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anantha Savithri |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
4th floor, Nehru Hospital, Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9538680995 |
| Fax |
|
| Email |
savithri1610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Karan Singla |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
4th floor, Nehru Hospital, Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592919073 |
| Fax |
|
| Email |
karansingla16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anantha Savithri |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
4th floor, Nehru Hospital, Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9538680995 |
| Fax |
|
| Email |
savithri1610@gmail.com |
|
|
Source of Monetary or Material Support
|
| 4th floor, Department of Anaesthesia and Intensive Care, Nehru Hospital, Post graduate Institute of Medical Education and Research, Sector 12, Chandigarh - 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh |
| Type of Sponsor |
Research institution |
|
|
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 Anantha Savithri |
PGIMER |
5th floor, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH |
9538680995
savithri1610@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone & Ondansetron |
Dexamethasone 8mg given after induction, Ondansetron 8mg given 30 minutes prior to extubation. |
| Intervention |
Haloperidol & Ondansetron |
Haloperidol 1mg given after induction, Ondansetron 8mg given 30 minutes prior to extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status I/II
Scheduled for laparoscopic procedures >1hr duration |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity or allergic reaction to ondansetron or haloperidol
2. Established diagnosis or family history of congenital long QT syndrome
3. Parkinsons disease
4. Use of anti emetic within 24 hours of surgery
5. Use of antipsychotic drugs
6. Pregnant patients
7. Obese patients (BMI >30)
8. Electrolyte abnormalities
9. Haemodynamic instability in the peri operative period |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of nausea using 11 point verbal numerical rating scale & number of episodes of vomiting
|
First 24 hours following laparoscopic gynaecological procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of rescue antiemetic |
First 24 hours following laparoscopic gynaecological procedure, & name of drug administered |
| Post operative analgesia |
First 24 hours following laparoscopic gynaecological procedure, using Visual Analog Score (VAS) |
| Extent of sedation |
First 24 hours following laparoscopic gynaecological procedure, using Observers assessment of alertness/sedation scale |
| Incidence of delirium using confusion assessment method (CAM) |
First 24 hours following laparoscopic gynaecological procedure |
| Time to administration of rescue antiemetic |
from end of procedure to occurrence of first episode of vomiting or sensation of nausea |
| corrected QT interval |
within first hour following laparoscopic gynaecological procedure |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/09/2023 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [karansingla16@gmail.com].
- For how long will this data be available start date provided 05-07-2024 and end date provided 05-07-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study aims to compare two drug combinations for prophylaxis of post operative nausea and vomiting in patients undergoing laparoscopic gynaecological procedures. Group DO: will receive 8mg dexamethasone after induction and 8mg ondansetron 30 minutes prior to extubation. Group HO: will receive 1mg haloperidol after induction and 8mg ondansetron 30 minutes prior to extubation.
Primary outcome assessed will be the incidence of nausea and number of episodes of vomiting in the first 24 hours following the procedure. |