| CTRI Number |
CTRI/2024/05/067391 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECT OF AMISULPRIDE FOR PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING BREAST SURGERIES |
|
Scientific Title of Study
|
SINGLE CENTRE, DOUBLE BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO EVALUATE EFFECTIVENESS OF AMISULPRIDE TO PREVENT POST OPERATIVE NAUSEA AND VOMITING IN FEMALE PATIENTS UNDERGOING BREAST SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jitendra Kumar Thakur |
| Designation |
Junior resident academic |
| Affiliation |
PGIMER Chandigarh |
| Address |
Post graduate institute of medical education and research sector 12 Chandigarh
Post graduate institute of medical education and research sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09310599009 |
| Fax |
|
| Email |
jkt.nmc2k9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIKAS SAINI |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh.
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008119 |
| Fax |
|
| Email |
drvsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIKAS SAINI |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER |
| Address |
DEPARTMENT OF ANAESTHEASIA AND INTENSIVE CARE, POST GRADUATE INSTITUE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH
DEPARTMENT OF ANAESTHEASIA & INTENSIVE CARE, POST GRADUATE INSTITUE OF MEDICAL EDUCATION AND REASEACH, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008119 |
| Fax |
|
| Email |
drvsaini@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA & INTENSIVE CARE, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH SECTOR 12 CHANDIGARH
PIN CODE 160012
INDIA |
|
|
Primary Sponsor
|
| Name |
DR JITENDRA KUMAR THAKUR |
| Address |
Department of Anaesthesia and Intensive Care Post-Graduate Institute of Medical Education and Research Chandigarh |
| 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 |
| DR JITENDER KUMAR THAKUR |
POST GRADUATE INSTITUE OF MEDICAL EDUCATION AND RESEARCH |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE POST GRADUATE INSTITUE OF MEDICAL EDUCATION AND RESEARCH SECTOR 12
Chandigarh
CHANDIGARH |
9310599009
jkt.nmc2k9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH INSTITUTIONAL ETHICS COMMITTEE {INTRAMURAL} |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (3) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amisulpride |
Amisulpride 5mg to be administered 30mins prior to completion of surgery
|
| Comparator Agent |
Ondansetron |
Ondansetron 0.1mg/kg 30mins prior to completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA-I,ASA-II and ASA-III
UNDERGOING BREAST SURGERY |
|
| ExclusionCriteria |
| Details |
History of hypersensitivity or allergic reaction to Amisulpride/ondansetron.
Hypokalemia (less than 3.0 mmol/L).
Prolactin-dependent tumor/pheochromocytoma.
Cardiac dysrhythmias
Congenital long QT
Pregnant female
The patient is on steroids preoperatively |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of emesis in 24 hours. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of nausea.
Use of rescue medication in the first 24 hours post-operatively.
Side effect. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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 Yet Recruiting |
| 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
|
The incidence of PONV in female patients undergoing breast cancer surgery is reported as 30%-68% even when patients have been administered intraoperative prophylactic antiemetics. Amisulpride is a dopamine receptor antagonist; D2 and D3. At low doses, amisulpride blocks presynaptic receptors, which facilitates dopamine release and thus resolves dopaminergic hypoactivity which prevents PONV. Efficacy in preventing PONV by prophylactic administration of a combination of amisulpride and ondansetron has not been studied in this setting. so, we hypothesized that prophylactic administration of a single-dose combination of amisulpride and ondansetron intraoperatively would decrease the incidence of PONV in female patients undergoing breast surgery.Incidence of PONV in female patients undergoing breast cancer surgery is reported as 30%-68% even when patients have been administered intraoperative prophylactic antiemetics, Amisulpride is a dopamine receptor antagonist; D2-D3. at low doses, amisulpride blocks presynaptic receptors, which facilitates dopamine release and thus resolves dopaminergic hypoactivity which prevents PONV. Efficacy in preventing PONV by prophylactic administration of a combination of amisulpride and ondansetron has not been studied in the setting. so, we hypothesized that prophylactic administration of a combination of amisulpride and ondansetron intraoperatively would decrease the incidence of POBNV in female patients undergoing breast surgery.
Reference: 1.
Kang C, Shirley M. Amisulpride: A Review in
Post-Operative Nausea and Vomiting. Drugs. 2021; 81:367-375.
2.
Gan TJ, Belani KG, Bergese
S, Chung F, Diemunsch P, Habib AS et al. Fourth
Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.
Anesth Analg. 2020; 131:411-448
3.
Couture DJ, Maye JP, O’brien D, Beldia Smith A.
Therapeutic modalities for the prophylactic management of postoperative nausea
and vomiting. J Perianesth Nurs. 2006; 21:398-403
4.
Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea
and vomiting: a simple yet complex problem. Anesth Essays Res. 2016; 10:388–96.
5.
Cao X, White PF, Ma H. An update on the management of
postoperative nausea and vomiting. J Anesth. 2017; 31:617-626.
6.
Tateosian VS, Champagne K, Gan TJ. What is new in the battle
against postoperative nausea and vomiting. Best Pract Res Clin Anaesthesiol.
2018; 32:137-148.
7.
Naylor RJ, Rudd JA. Pharmacology of ondansetron.
Eur J Anaesthesiol Suppl. 1992; 6:3-10.
8.
Layeeque R, Siegel E, Kass R, Henry-Tillman RS, Colvert M, Mancino
A, et al. Prevention of nausea
and vomiting following breast surgery. Am J Surg. 2006; 191:767–72.
9.
Matchock RL, Levine ME, Gianaros PJ, Stern
RM. Susceptibility to nausea and motion sickness as
a function of the menstrual cycle. Women’s
Health Issues. 2008; 18:328–35
10. Piechotta V, Adams A, Haque M, Scheckel B, Kreuzberger N, Monsef I.
Antiemetics for adults for prevention of nausea and vomiting caused by
moderately or highly emetogenic chemotherapy: a network meta-analysis. Cochrane Database Syst Rev. 2021; 16;11:CD012775.
11 Fox G, Kranke P. A
pharmacological profile of intravenous amisulpride for the treatment of
postoperative nausea and vomiting. Expert Rev Clin Pharmacol. 2020; 13:331–40.
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