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

NCT ID: NCT07087925

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-05-15

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.

Detailed Description

Postoperative nausea and vomiting (PONV) remains one of the most common and distressing complications following surgery. Even with the use of regional anesthesia such as subarachnoid block (SAB), patients may still experience PONV, which affects recovery quality and increases healthcare burdens. Although antiemetic agents like ondansetron are commonly used, comparative studies evaluating alternative drugs such as haloperidol are limited, particularly in the context of spinal anesthesia.

This study was conducted to fill this gap by comparing the effectiveness of intravenous haloperidol and ondansetron in preventing PONV in patients undergoing surgery with subarachnoid block. The trial was carried out at RSUP H. Adam Malik Medan and Rumah Sakit Umum Haji Medan in Indonesia. A total of 40 male patients were recruited and randomly assigned into two groups to receive either intravenous haloperidol or ondansetron during the intraoperative period. The study design was double-blind, ensuring that both participants and medical personnel were unaware of the treatment allocations.

The primary outcome measured was the incidence of PONV within 24 hours after surgery. Data collection included patient demographics, APFEL risk scores, side effects (if any), and clinical observations. The haloperidol group had significantly fewer cases of PONV (2.5%) compared to the ondansetron group (30%). Additionally, both treatments were well tolerated with minimal adverse events. One case of mild sedation was noted in the haloperidol group, but no serious complications occurred in either group.

This study concludes that intravenous haloperidol is more effective than ondansetron in reducing PONV among male patients undergoing spinal anesthesia. Given its cost-effectiveness and favorable safety profile, haloperidol may be considered as an alternative antiemetic in clinical settings, particularly in resource-limited environments. However, further studies involving larger, gender-balanced populations are recommended to validate these findings and expand their generalizability.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Haloperidol IV Group

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.

Group Type: EXPERIMENTAL

Haloperidol

Intervention Type: 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.

Ondansetron IV Group

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.

Group Type: ACTIVE_COMPARATOR

Ondansetron 4mg

Intervention Type: 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.

Interventions

Haloperidol

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.

Intervention Type: DRUG

Ondansetron 4mg

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rully Riyandika

OTHER

Sponsor Role: lead

Responsible Party

Rully Riyandika

Sumatera Utara University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

RSUP H. Adam Malik Medan

Medan, North Sumatra, Indonesia

Countries

Indonesia

Other Identifiers

1511/KEPK/USU/2024

Identifier Type: OTHER

Identifier Source: secondary_id

HALO-ONDAN-PONV-RA-SAB

Identifier Type: -

Identifier Source: org_study_id