A CLINICAL TRIAL TO STUDY THE EFFECT OF AMISULPRIDE FOR PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING BREAST SURGERIES

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067391

Enrollment

136

Registered

2024-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C503- Malignant neoplasm of lower-innerquadrant of breast Health Condition 3: C505- Malignant neoplasm of lower-outerquadrant of breast

Interventions

Intervention1: Amisulpride: Amisulpride 5mg to be administered 30mins prior to completion of surgery Control Intervention1: Ondansetron: Ondansetron 0.1mg/kg 30mins prior to completion of surgery

Eligibility

Inclusion criteria

Inclusion criteria: ASA-I,ASA-II and ASA-III UNDERGOING BREAST SURGERY

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare the incidence of emesis in 24 hours.Timepoint: 24 hours	—

Secondary

Measure	Time frame
Incidence of nausea. Use of rescue medication in the first 24 hours post-operatively. Side effect.Timepoint: 24 hours	—

Countries

India

Contacts

Public ContactDR VIKAS SAINI

PGIMER, CHANDIGARH

drvsaini@gmail.com7087008119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026