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A study to compare two medicines namely Amisulpride and Ondansetron in reducing nausea and vomiting in breast cancer patients after chemotherapy

Comparison of effect of Amisulpride and Dexamethasone with Ondansetron and Dexamethasone for postoperative nausea and vomiting after post-chemotherapy breast cancer surgeries: A Randomised Active Controlled Double Blind Study - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066189
Enrollment
202
Registered
2024-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: C50-C50- Malignant neoplasms of breast Health Condition 2: O- Medical and Surgical Health Condition 3: R11- Nausea and vomiting

Interventions

Intervention1: Group A: Amisulpride + Dexamethasone: Group A patients will receive IV Amisulpride 5 mg + Dexamethasone 4 mg In addition, patients in group A will receive IV normal saline 2ml three ti

Sponsors

Dr Sohan Lal Solanki
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients age more than 18 years 2. Post-chemotherapy breast cancer patients 3. Posted for mastectomy or breast conservative surgery including type 1 and type 2 onco-plasty 4. ASA I-III

Exclusion criteria

Exclusion criteria: 1. Consent refusal 2. Expected surgical duration more than 4 hours. 3. Patients with mental and cognitive dysfunction 4. Active smoker or history of smoking 5. History of allergy to amisulpride/ondansetron/dexamethasone 6. Patients with uncontrolled diabetes mellitis (HbA1c more than 8.5percent or Fasting Blood Sugar more than 180 mg/dl) 7. Patients with extrapyramidal disorders. 8. Patients with acute or chronic kidney disease. 9. Use of opioids, corticosteroids, psychoactive drugs or any other medication with known emetic or antiemetic effect within 24 hrs prior to surgery

Design outcomes

Primary

MeasureTime frame
Overall incidence of PONV between the two groupsTimepoint: Every half an hour for 2 hours in postanesthesia care unit and then in the ward at intervals of 2 to 6, 6 to 12 and 12 to 24 hours postoperatively

Secondary

MeasureTime frame
To compare the intensities of nausea and painTimepoint: Every half an hour for 2 hours in postanesthesia care unit and then in the ward at intervals of 2 to 6, 6 to 12 and 12 to 24 hours postoperatively

Countries

India

Contacts

Public ContactRutuja Chavan

Tata Memorial Hospital

sohan.solanki@gmail.com9869253201

Outcome results

None listed

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