Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Injection Amisulpride: Patients will receive Inj. Amisulpride (5 mg) diluted with normal saline (3 ml) I.V slowly given over 1-2 minutes at the time of induction only
Control Interventi
Sponsors
GMERS Medical College and Hospital Gotri Vadodara
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 60 years, weight 40 to 80 kg, of either sex. American society of anaesthesia grading I and II. Surgery under general inhalational anaesthesia with expected duration of minimum one hour. Patients with two or more risk factors for PONV.
Exclusion criteria
Exclusion criteria: Allergy to the study drug. Pregnancy and Breastfeeding mother. Known case of Cardiac arrhythmias, Congenital QT syndrome, QTc more than 420msec. History of epilepsy, Parkinsons disease. Patients who had received Amisulpride for any other indication in two weeks before surgery or patients on antipsychotic therapy e.g. Levodopa. Patient is known case of prolactin dependent tumours e.g. pituitary gland prolactinoma, pheochromocytoma. Patients who have difficulty in expressing numerical rating scale like hearing disability, mentally challenged, dementia or psychiatric illness. Hypokalaemia serum POTASSIUM Level less than 3.0 mmol per liter. Patients who had received any emetogenic anticancer therapy in previous 4 weeks. Patients on chronic Opioid therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in complete response no episode of nausea and vomiting in the next 24 hour period after surgery, and no requirement for additional antiemetic rescue medication between both the groups. Timepoint: Initial 24 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in incidence & severity of nausea by NRS score between both the groups. Comparing the need of rescue medication in both the groups. To assess adverse effects associated with both the groups. Timepoint: Initial 24 hours after surgery | — |
Countries
India
Contacts
Public ContactDrDhara Tanna
GMERS Medical College and Hospital, Gotri, Vadodara
Outcome results
None listed