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comparison of amisulpride with ondansetron versus dexamethasone with ondansetron in prevention of post operative nausea and vomiting in patients going for gall bladder removal surgeries.

Intravenous Amisulpride with intravenous Ondansetron versus intravenous Dexamethasone with intravenous Ondansetron in prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: A Double-Blind Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094850
Enrollment
60
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Intravenous Amisulpride with intravenous Ondansetron: Intravenous Amisulpride 5mg bolus with intravenous Ondansetron 4mg bolus will be given in first 30min of surgery total lasting for

Sponsors

Dr Ashutosh Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Scheduled to undergo elective laparoscopic cholecystectomy under general anaesthesia lasting for atleast 1 hour under GA with inhalational agent. 2) Ability to provide informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of severe adverse reactions to any of the study medications. 2) Known hypersensitivity to any of the study drugs. 3) History of significant cardiac, renal, hepatic, or neurological disorders. 4) Pregnancy or breastfeeding. 5) Use of antiemetic medications within 24 hours prior to surgery. 6) Chronic opioid use or history of substance abuse.

Design outcomes

Primary

MeasureTime frame
1) To evaluate the incidence of emetic episodes within 24 hours post-surgery in both treatment groups. 2) To assess the severity of nausea at 1, 2, 6 and 24 hours post-surgery in both treatment groups using a patient verbal rating scale. 3) To predict the incidence of PONV using the Apfel scoring system in both treatment groups. Timepoint: To assess at 1st, 2nd, 6th and 24th hour post-surgery

Secondary

MeasureTime frame
To determine the need for rescue medication for PONV in each treatment groups Timepoint: Within 24hours

Countries

India

Contacts

Public ContactDr Ashutosh Singh

Shri Guru Ram Rai Institute of Medical and Health Sciences , Dehradun

drashutoshsingh17@gmail.com9540947103

Outcome results

None listed

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