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

NCT06428084 | Completed Phase 2 DMC

• 1 other identifier: AN-202405.01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Nausea and Vomiting Score

  Score 0 (No nausea, no vomiting); Score 1 (Nausea present, no vomiting); Score 2 (Nausea present, vomiting present); Score 3 (Vomiting \>2 episodes in 30 minutes)

  24 hours post-operation

Study Arms (2)

Ondansetron

ACTIVE COMPARATOR

19 participants in group O received 4 mg of ondansetron intravenously.

Drug: Ondansetron

Haloperidol

ACTIVE COMPARATOR

19 participants in group H received 1 mg of Haloperidol intravenously.

Drug: Haloperidol

Interventions

Ondansetron DRUG

4 mg of ondansetron intravenously

Ondansetron

Haloperidol DRUG

1 mg of Haloperidol intravenously

Haloperidol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparoscopic cholecystectomy
• aged 18 - 65 years
• ASA physical status 1 and 2
• Apfel score ≥2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Interventions

Ondansetron; Haloperidol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Dian Mardiani, M.D

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 24, 2024
• Study Start: November 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)