| CTRI Number |
CTRI/2024/09/074150 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A difference between Amisulpride Vs Ondansetron for prevention of post operative nausea and vomiting in patient undergoing laparoscopic surgeries. |
|
Scientific Title of Study
|
A comparative study between Amisulpride Vs Ondansetron for prevention of post operative nausea and vomiting in laparoscopic 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 HARI GOVINDH A |
| Designation |
Post graduate in Department of Anaesthesiology |
| Affiliation |
RajaRajeswari Medical College and Hospital |
| Address |
Rajarajeswari medical college and hospital, Mysore road, Kambipura
Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
9585700141 |
| Fax |
|
| Email |
doctorhari41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Rangalakshmi |
| Designation |
Head of Department |
| Affiliation |
RajaRajeswari Medical College and Hospital |
| Address |
Department of Anaesthesiology RajaRajeswari Medical College and
Hospital 202, Mysore Road Kengeri Satellite Town Kambipura
Bangalore
KARNATAKA
560074
India |
| Phone |
9901703030 |
| Fax |
|
| Email |
rangbharat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sowmya MJ |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
RajaRajeswari Medical College and Hospital |
| Address |
Department of Anaesthesiology RajaRajeswari Medical College and
Hospital 202, Mysore Road Kengeri Satellite Town Kambipura
Bangalore
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology RajaRajeswari Medical College and Hospital,202, Mysore Rd,
Kengeri Satellite Town, Kambipura, Bengaluru, Karnataka 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Hari Govindh A |
| Address |
RajaRajeswari Medical College and Hospital 202, Mysore Rd,
Kengeri Satellite Town, Kambipura, Bengaluru, Karnataka 560074 |
| 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 Hari Govindh A |
RajaRajeswari Medical College and Hospital |
Department of
Anaesthesiology,
RajaRajeswari Medical
College and Hospital
202, Mysore Rd,
Kengeri Satellite Town,
Kambipura.
Bangalore
KARNATAKA |
9585700141
doctorhari41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amisulpride |
It is a selective antagonist of dopamine D2 and D3 receptors. It belongs to the benzamide atypical antipsychotic drug class. It has a much higher affinity for dopamine receptors compared to other receptors, such as serotonin or histamine receptors. I.v 5mg Amisulpride over 2mins prior 20 mins before extubation is given. |
| Intervention |
Ondansetrone |
It is a selective 5-HT3 serotonin-receptor antagonist used for its antiemetic properties. It is one of the four FDA-approved 5-HT3 serotonin-receptor antagonists used to combat nausea and vomiting, including granisetron, dolasetron, and the second-generation drug, palonosetron. I.v 4mg Ondansetrone is given as bolus prior 20 mins extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing general anesthesia with endotracheal intubation for laproscopic surgeries |
|
| ExclusionCriteria |
| Details |
1.Patients having allergies to the drug.
2.Transplant surgery or any surgery where postoperative emesis could pose a significant danger to the patient.
3.Had received Amisulpride for any indication in the 2 weeks before screening.
4. H/O vestibular disease or dizziness, were receiving regular anti-emetic therapy, still going on within 1 week before surgery, had a known prolactin-dependent tumor or Pheochromocytoma.
5. Pregnant or breastfeeding.
6.Clinically significant cardiac arrhythmia or congenital QT syndrome, had a h/o epilepsy or Parkinson’s disease or were being treated with levodopa. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare two drugs intraoperatively to see the effect of post op nausea and vomiting |
15min
30min
45min
60min
1.30hour
2.00hour
2.30hour
3.00hour
6th hour
12th hour
18th hour
24th hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between Amisulpride and Ondansetron for prevention of postoperative nausea and vomiting in laparoscopic surgery.
To determine any complications in study drugs Amisulpride and Ondansetron.
|
15min
30min
45min
60min
1.30hour
2.00hour
2.30hour
3.00hour
6th hour
12th hour
18th hour
24th hour
|
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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 2 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Patient will be randomised into two groups, group
A (Amisulpride 5mg) and group C (Ondansetron 8mg-conventional drug). Using
computer generated simple randomised numbers. The group allocation will be done
by PI sealed envelope type. Patient will be accepted for surgery after
evaluation and optimisation. Informed consent will be taken for anaesthetic
procedure and for the study. anaesthetists.
Prior 20min before extubation, group Patients will be
given Inj Amisulpride 5mg by intravenous over 1min and group C patients will be
given Inj Ondansetron 8mg by intravenous over 1 min. Patient extubated and will
be shifted to recovery room for observation. Monitor the
patients for every 15mins for 1st hour, every 30mins for 2hours and
thereafter every 6th hourly. Rescue
anti emetic to be given postoperatively to any patient with nausea, from which
they requested relief. |