| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS JODHPUR |
| 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 |
| 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
|
|
|
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. |