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Effectiveness of amisulpride versus dexamethasone for control of nausea and vomiting after laparoscopic gall bladder removal operation.

Efficacy of amisulpride versus dexamethasone for post operative nausea and vomiting prophylaxis in patients undergoing laparoscopic cholecystectomy- a randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064843
Enrollment
120
Registered
2024-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Amisulpride: Group A- will receive 5mg of Amisulpride Control Intervention1: Dexamethasone: Group D- will receive 8mg of Dexamethasone

Sponsors

Dr Amit Pradhan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1& 2 Patients posted for elective Laparoscopic cholecystectomy under endotracheal general anaesthesia

Exclusion criteria

Exclusion criteria: 1.Any hypersensitivity to the study drugs 2.Administration of antiemetic/steroid 24 hrs prior to anaesthesia 3.Administration of Emetogenic anticancer chemotherapy in previous 4 weeks 4.Pregnant/lactating females 5.Patients on treatment with levodopa/ carbidopa 6.Cardiac arryhthmia, QT interval abnormality 7.Hypokalemia,hypomagnesemia 8.Pre-existing vestibular disease 9.Need of naso/oro-gastric tube after surgery 10.Requirement of post operative mechanical ventilation

Design outcomes

Secondary

MeasureTime frame
1 Incidence and severity of significant nausea 2 Incidence of retching or vomiting 3 Time to first requirement of rescue antiemetic 4 Number of times of requirement of rescue antiemetic 5 VAS Score for pain 6 Adverse effects like infusion site pain, constipation and flatulence Timepoint: 24 hours

Primary

MeasureTime frame
To compare the proportion of Complete Response(defined as no episodes of nausea, retching or vomiting) upto first 24 hours after surgeryTimepoint: 24hours

Countries

India

Contacts

Public ContactDr K B Tharun Kumar

KIMS, Bhubaneswar

dr.sapnadas88@gmail.com9078826164

Outcome results

None listed

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