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Comparing Ondansetron with Low-Dose Steroids to Avoid Nausea and Vomiting Following Gallbladder Surgery

A Comparison of Low Dose Methylprednisolone vs. Dexamethasone Along With Ondansetron in Preventing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084213
Enrollment
80
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Control Intervention1: Dexamethasone with ondansetran: Patient will receive Intravenous dexamethasone 0.1mg/kg & Intravenous ondansetron 4mg at the start of the surgery Control Intervention2: Low Dose

Sponsors

Department of Anesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status I-II of either gender 2. Patient scheduled for laparoscopic cholecystectomy under general anesthesia 3. Non-smoker

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Lactation 3. History of major surgery within the past 3 months 4. Inability to provide informed consent 5. H/O allergy or hypersensitivity to any study drugs 6. H/O pre-existing nausea or vomiting 7. H/O GI mobility disorders 8. H/O peptic ulcer disease 9. H/O use of anti-emetics, steroids, anti-histamines.

Design outcomes

Primary

MeasureTime frame
To Compare the incidence of post operative nausea and vomiting,within the first 24 hours after surgery in patients receiving ondansetran with either low dose of methylprednisolone or dexamethasone.Timepoint: Vomiting Early 1st hour Vomiting Late 6th hour Vomiting Late 24th hour

Secondary

MeasureTime frame
1. To assess the severity of PONV, including the number & intensity of nausea & vomiting episodes. 2. To evaluate the need for rescue antiemetics in each treatment group. 3. To compare the safety profile of low-dose methylprednisolone, dexamethasone, & ondansetron, including the incidence & severity of adverse effects.Timepoint: vomiting early 1st hour vomiting late 6th hour vomiting late 24th hour

Countries

India

Contacts

Public ContactNilesh M

st Johns Medical College and hospital

drarpanak@hotmail.com9945346123

Outcome results

None listed

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