Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Maulana Azad Medical College