| CTRI Number |
CTRI/2024/10/075431 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Low and High Doses of Amisulpride to Prevent Nausea and Vomiting in Ear Surgery |
|
Scientific Title of Study
|
To Compare Safety And Efficacy Of Low Dose And High Dose Of Intravenous Amisulpride In Prevention Of Nausea And Vomiting In Middle Ear Surgeries |
| 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 Paigam Prinja |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9779077607 |
| Fax |
|
| Email |
drpropofol.prinja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Ahluwalia |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College |
| Address |
Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8218628850 |
| Fax |
|
| Email |
pallaviahluwalia22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Ahluwalia |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College |
| Address |
Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8218628850 |
| Fax |
|
| Email |
pallaviahluwalia22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur Moradabad 244001 India |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre, NH-24, Bagadpur Moradabad |
| Type of Sponsor |
Private medical college |
|
|
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 Paigam Prinja |
TMU Hospital |
Department Of Anaesthesiology 2nd Floor Teerthanker Mahaveer Medical College and Research Centre NH-24 Bagadpur
Moradabad
UTTAR PRADESH |
9779077607
drpropofol.prinja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University-Institutional Ethics Committee |
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 |
Injection Amisulpride |
10 mg IV Route 30 mins before extubation |
| Intervention |
Injection Amisulpride |
5mg IV route 30 mins before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for Elective Middle Ear Surgeries
Patient giving written and informed consent
American Society of Anesthesiologist (ASA) grade I-II[7]
Age group of 18-65 years old
Apfel Score ≥ 2 |
|
| ExclusionCriteria |
| Details |
Patient on any Psychotropic drug
smokers
Pregnant Females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To note occurrence of Intraoperative Nausea and Vomiting
To compare severity of Nausea Vomiting for 24 hours |
Baseline( At time of Extubation)
15 mins
30 mins
45 mins
1 hour
2 hours
3 hours
4 hours
8 hours
12 hours
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time for onset of first episode of Nausea Vomiting
To compare the efficacy of intravenous amisulpride by noting the Verbal Rating Score (VRS)
To compare total rescue medication given
To record any complications |
Baseline( At time of Extubation)
15 mins
30 mins
45 mins
1 hour
2 hours
3 hours
4 hours
8 hours
12 hours
24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
09/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study aims to compare the safety and efficacy of low-dose (5mg) and high-dose (10mg) intravenous amisulpride in preventing postoperative nausea and vomiting (PONV) in patients undergoing middle ear surgeries. These surgeries increase the risk of PONV due to vestibular stimulation from drilling and irrigation. Amisulpride, a D2-D3 antagonist, has shown effectiveness in preventing PONV, though the optimal dose remains unclear. |