Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: INJ AMISULPRIDE: Amisulpride
monotherapy group shall receive 5mg of IV amisulpride medication which will be administered
by slow i.v. push over 2 min at the end of surgery.
Interventi
Sponsors
Jubilee mission medical college and research institute
Eligibility
Inclusion criteria
Inclusion criteria: Age more than 18 years. Consenting for the study. Undergoing middle ear surgery under general Anaesthesia lasting more than one hour. Must have at least two of the following risk factors (i) female gender (ii) non-smoker (iii) a prior history of PONV or motion sickness; and (iv) Receiving postoperative opioid analgesia. Normal hematological, renal, and hepatic function. ASA (American society of Anaesthesiologists) Grade 1 & Grade 2.
Exclusion criteria
Exclusion criteria: Patients requiring postoperative ventilation. Naso-gastric tube in situ after surgery. Clinically significant cardiac arrhythmia, pre-existing vestibular disorder, history of dizziness, alcohol abuse, epilepsy, Parkinsons disease. Any antiemetic drug received in the last 12 hours. BMI more than 35 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the complete response (CR), defined as no episodes of emesis (vomiting or retching) and no rescue medication in the first 24 hours after surgery.Timepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variables include the incidence of the individual parameters, emesis, significant nausea, any nausea, and use of rescue medication in the time periods half an hour, 1 hour, 2 hours, 6 hours, 12 hours and 24 hours after surgery. The safety and tolerability of amisulpride, ondansetron and their combination therapy will be assessed by recording reported by patients or observed by nursing staff, within 24 hours after surgeryTimepoint: 24hours | — |
Countries
India
Contacts
Public ContactRiya Alex
KUHS
Outcome results
None listed