Comparison of Haloperidol and Ondansetron in Reducing Postoperative Nausea and Vomiting in RA-SAB Patients

NCT07087925 | Completed

• 2 other identifiers: HALO-ONDAN-PONV-RA-SAB1511/KEPK/USU/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate and compare the effectiveness of intravenous haloperidol and ondansetron in preventing postoperative nausea and vomiting (PONV) in patients undergoing surgery with subarachnoid block (spinal anesthesia). PONV is a common postoperative complication that can delay recovery, cause patient discomfort, and increase healthcare costs. In this randomized, double-blind, prospective trial, eligible male patients aged 18-60 years undergoing elective surgeries under regional anesthesia were enrolled. Participants were assigned to receive either haloperidol or ondansetron during the intraoperative period. Both drugs are widely used antiemetic agents: haloperidol is a dopamine receptor antagonist, and ondansetron is a serotonin 5-HT3 receptor antagonist. The primary objective was to assess the incidence of PONV within 24 hours after surgery. Results showed that haloperidol significantly reduced PONV incidence compared to ondansetron, with minimal adverse effects. The study suggests that intravenous haloperidol may be a cost-effective and well-tolerated alternative to ondansetron for PONV prevention in selected patients undergoing spinal anesthesia.

Conditions

Postoperative Nausea and Vomiting (PONV); Subarachnoid Block; Spinal Anesthesia

Keywords

Haloperidol; Ondansetron; PONV; Regional Anesthesia; Subarachnoid Block; Spinal Anesthesia; Antiemetic Agents; Intraoperative Management; Postoperative Complications; Double-Blind Randomized Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Nausea and Vomiting (PONV) within 24 Hours After Surgery

  The occurrence of postoperative nausea and/or vomiting was assessed using a validated simplified PONV impact scale. Patients were monitored for symptoms such as nausea, vomiting, or dry retching within 24 hours after receiving either haloperidol or ondansetron. The outcome was recorded as binary (Yes/No).

  Within 24 hours postoperatively

Study Arms (2)

Haloperidol IV Group

EXPERIMENTAL

Participants in this arm received a single dose of intravenous haloperidol (1-2 mg) administered intraoperatively during surgery under subarachnoid block (RA-SAB). The goal was to evaluate its effectiveness in preventing postoperative nausea and vomiting (PONV). The administration was performed under blinded conditions, and patients were monitored for PONV occurrence and side effects for 24 hours postoperatively.

Drug: Haloperidol

Ondansetron IV Group

ACTIVE COMPARATOR

Participants in this arm received a single dose of intravenous ondansetron (4 mg) administered intraoperatively during surgery under subarachnoid block (RA-SAB). This group served as the active comparator to assess the relative effectiveness of ondansetron versus haloperidol in preventing PONV. Monitoring included assessment of PONV incidence and side effects for 24 hours postoperatively.

Drug: Ondansetron 4mg

Interventions

Haloperidol DRUG

A single dose of haloperidol (1-2 mg) was administered intravenously during the intraoperative period to patients undergoing surgery under subarachnoid block (RA-SAB). This intervention was designed to evaluate its effectiveness in preventing postoperative nausea and vomiting (PONV). Both patients and providers were blinded to the assignment.

Haloperidol IV Group

Ondansetron 4mg DRUG

A single dose of ondansetron (4 mg) was administered intravenously during the intraoperative period to patients undergoing surgery under subarachnoid block (RA-SAB). This intervention served as the active comparator to haloperidol in evaluating the prevention of postoperative nausea and vomiting (PONV). The study was conducted in a double-blind manner.

Ondansetron IV Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients aged 18-60 years
• Undergoing elective surgery under regional anesthesia (Subarachnoid Block)
• Non-smokers
• Hemodynamically stable
• Surgical site involving gastrointestinal, pelvic, genital, perineal, or urologic regions
• Supine surgical position

You may not qualify if:

• Use of combined spinal and epidural anesthesia
• Known allergy to haloperidol or ondansetron
• Systemic infection, neuropathy, or coagulopathy
• Severe anxiety, psychiatric, or neuromuscular conditions
• Hormonal imbalances, gastritis, or pregnancy
• Conversion to general anesthesia due to block failure
• Intraoperative complications such as shock
• Abnormally prolonged surgery duration

Sponsors & Collaborators

• Rully Riyandika: lead

Study Sites (1)

RSUP H. Adam Malik Medan

Medan, North Sumatra, 20155, Indonesia

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Postoperative Complications

Interventions

Haloperidol; Ondansetron

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind masking: Both participants and clinical team members, including data collectors and assessors, were unaware of the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sumatera Utara University

Model Details: A two-arm, randomized, double-blind, parallel assignment study comparing haloperidol and ondansetron administered intraoperatively to prevent PONV in patients undergoing subarachnoid block anesthesia.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 28, 2025
• Study Start: January 15, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 15, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD and supporting documents will be available starting 6 months after publication of the main study results and will remain accessible for 3 years thereafter.
• Access Criteria: Qualified researchers may request access to the de-identified data and supporting materials for academic and non-commercial use. Requests must include a brief research proposal and data use agreement, and will be reviewed by the principal investigator. Approved users will receive data via secure email or institutional repository.

Locations

ID (1)