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To compare i.v promethazine and i.v amisulpride for the treatment of post operative nausea and vomiting in female patients after receiving general anaesthesia

Comparison of intravenous amisulpride with promethazine for the treatment of postoperative nausea and vomiting in female patients after general anaesthesia: A double-blind randomised study - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092407
Enrollment
224
Registered
2025-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intravenous amisulpride: One group of female patients having postoperative nausea and vomiting will receive i.v amisulpride 10 mg Control Intervention1: Intravenous promethazine: Anothe

Sponsors

Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Female patients undergoing elective surgical procedures under general anaesthesia who are ASA 1,2 or 3

Exclusion criteria

Exclusion criteria: Pregnant and lactating mothers Patients undergoing total intravenous anaesthesia Significant ongoing vestibular disease or dizziness Known prolactin dependant tumours or pheochromocytoma Those with clinically signicant cardiac arrhythmias or long QT syndrome Patients with substance abuse History of psychiatric illness epilepsy or Parkinson s disease Documented allergy to amisulpride or any other dopamine antagonists drugs

Design outcomes

Primary

MeasureTime frame
Proportion of patients with complete response to treatment dose of amisulpride or promethazine. The complete response will be defined as :cessation of nausea , retching or vomiting with no recurrence and no rescue medications in the 4 hrs after administration, excluding any emesis events in first 15 minutes Timepoint: 4 hrs after shifting the patient to PACU

Secondary

MeasureTime frame
Mean verbal descriptive scale (VDS) score for nauseaTimepoint: At 5 minute interval upto 30 minutes and at 2,6,12,24 hrs after administration of study drugs;Number of episodes of emesis after administration of study drugsTimepoint: ;Mean time to achieve complete responseTimepoint: ;Total no. Of doses of rescue antiemetics after surgeryTimepoint: At 24 hrs;Any side effects of study drugsTimepoint: ;Mean postoperative quality recovery -15 scoreTimepoint: At 24 hrs after surgery

Countries

India

Contacts

Public ContactDr Bharti Goel

Maulana Azad Medical College

drsukhi25@gmail.com9968527122

Outcome results

None listed

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