CompletedPhase 2

Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing PONV

Indonesia38 participantsStarted 2023-11-01

Plain-language summary

Nausea and vomiting following laparoscopic cholecystectomy remain common, with occurrence rates of 40-70% during the initial 24 hours post-operation. The underlying mechanisms of postoperative nausea and vomiting engage five distinct neurotransmitter receptors. Consequently, employing a combination of antiemetics from diverse classes that target various receptors for effective prevention is advised. Ondansetron's antiemetic properties derive from its ability to inhibit serotonin receptors, whereas Haloperidol targets dopamine receptors, and Dexamethasone reduces prostaglandin production.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing laparoscopic cholecystectomy * aged 18 - 65 years * ASA physical status 1 and 2 * Apfel score ≥2 Exclusion Criteria: * a history of allergies * routine use of antipsychotic drugs, steroids, antihistamines, and antiemetics before surgery * cardiac rhythm disorders * elevated liver enzyme levels (SGOT/SGPT) ≥5 times upper limit normal * BMI ≥35 kg/m2 Dropout Criteria: * if they experienced hypotension, defined as systolic blood pressure below 90 mmHg or mean arterial pressure (MAP) below 60 mmHg, or a decrease in systolic blood pressure and/or MAP greater than 20% from baseline for a duration exceeding two minutes, surgical procedures extending \>3 hours, and any alterations in the planned surgical intervention.

What they're measuring

Nausea and Vomiting Score

Timeframe: 24 hours post-operation

Trial details

NCT IDNCT06428084

SponsorUniversitas Padjadjaran

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-28