A comparative study to evaluate efficay, Of intravenous palonosetron vs amisulpride. For post operative nausea and vomiting under general anaesthesia - a randomised study

To compare antiemetic efficacy of intravenous administration of Inj.palonosetron and Inj. amisulpride for post operative nausea and vomiting under general anaesthesia.

OBJECTIVES is to study the complete response of drugs i.e. no episodes of emesis and no use of rescue medication in first 24 hours after surgery or PONV and to observe the incidence of nausea, vomiting, use of rescue medicine and any adverse events.

Inclusion criteria: Surgery to last at least 1-hour, Overnight stay, General anaesthesia, ASA I&II and At least one of the following Apfel et al

Risk factors for PONV Female sex, Non-smoking status, A prior history of PONV or motion sickness and being expected to receive postoperative opioid analgesia

Exclusion Criteria If any antihistaminic, continuous infusion of propofol or dexmedetomidine, steroids,  any antiemetics is used 24 hours prior or post-surgery then the case will be not selected for the study, Cardiac surgery, Intrathoracic, Transplant, CNS surgery, If required post-operative ventilation, Need a nasogastric tube in situ, Parkinson’s disease, Pre-existing vestibular disorder, History of dizziness, Alcohol abuse, Cardiac arrhythmia, Epilepsy, Emergency surgery, ASA III and above, Morbid obesity if weight greater than 120kg,Renal or liver disease, Pregnancy, Hypersensitivity and Known allergy

We will be conducting this on 60 adults aged 18-65yrs belonging to grade I and II of American Society of anaesthesiologists (ASA) classification who will undergo operation under general anaesthesia. They will be divided into 2 equal groups based on chit method.

Group A will receive palonosetran 0.075mg and Group B receive 5mg amisulpride and. Each group will have 30 patients based on chit method and the study drug will be administered by the consultant anaesthesiologist present in the operation theatre there. Haemodynamic parameters will be noted post-operatively at 0,2,6,8,12, 24, 48hours.Rescue antiemetic will be given upon VRS of more than or equal to 4 score i.e. moderate nausea in form of ondansetron 4 mg

Episodes of emesis (vomiting or retching) and use of rescue medication will be recorded. Nausea (scored using a self-reported 11-point verbal scale, where 0 represented no nausea and 10 the worst nausea possible) was assessed Predose and at 5, 15, and 30 minutes and 2 hours after administration of study medication. Any nausea episodes spontaneously reported by the patient in the 24-hour period will also be scored and recorded.

Site of Study Department of anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and research Centre, Piparia, Waghodia, Vadodara from 2024-2025

Study Design Prospective observational study

 Study Duration The study will be initiated after obtaining permission from institutional ethics committee till the achievement of the sample size or completion of time period of study whichever is earlier.

Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student-t test and/or ANNOVA will be used wherever appropriate for between-groups comparisons, while for categorical variables; chi-square test will be used. P value <0.05 will be considered statistically significant.

LIKELY OUTCOME/BENEFITS OF STUDY We will get to know the efficacy of and safety of intravenous amisulpride as a sole agent to prevent post-operative nausea vomiting, Early ambulation of the patient and less stay in hospital and bed occupancy thus reducing economic burden.