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A STUDY TO EVALUATE EFFICIENCY OF PALONOSETRON VS AMISULPRIDE FOR POST OPERATIVE NAUSEA AND VOMITING UNDER GENERAL ANAESTHESIA

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083546
Enrollment
60
Registered
2025-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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: inj.palonosetran 0.075mg: Group A will receive palonosetran 0.075mg iv 15 min before surgery Control Intervention1: inj.amisulpride 5mg: Group B receive inj.amisulpride 5mg iv 15 min be

Sponsors

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Surgery to last at least 1 hour 2 Overnight stay 3 General anaesthesia 4 ASA I&II 5 At least one of the following Apfel et al’s risk factors for PONV: 6 Female sex 7 Non-smoking status 8 A prior history of PONV or motion sickness 9 Being expected to receive postoperative opioid analgesia

Exclusion criteria

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 Parkinsons disease Pre-existing vestibular disorder History of dizziness

Design outcomes

Primary

MeasureTime frame
To study efficacy and safety between intravenous PALONOSETRON and AMISULPRIDE to prevent post-operative nausea vomiting.Timepoint: patient will assed at 1st,2nd,6th,12th,24th hour intervels after surgery—

Secondary

MeasureTime frame
•to study efficacy and safety between intravenous PALONOSETRON and AMISULPRIDE to prevent post-operative nausea vomiting.Timepoint: • Efficacy was assessed during the 48 hours after administration of the study drug Episodes of emesis vomiting or retchingband the use of rescue medication were recorded. Nausea scored using a self-reported 11-point verbal scale where 0 represented no nausea and 10 was the worst nausea possible was assessed Predose at 5 15 and 30 minutes and 2 hours after administration of study medication Any nausea episodes spontaneously reported by the patient in the 48 hours was also scored and recorded.—

Countries

India

Contacts

Public ContactDr Dinesh Chauhan

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

drdinesh77@gmail.com9099014672

Outcome results

None listed

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