Postoperative Nausea and Vomiting (PONV)HALO-PONVNCT07087925
Comparison of Haloperidol and Ondansetron in Reducing Postoperative Nausea and Vomiting in RA-SAB Patients
A study testing Haloperidol and Ondansetron 4mg in people with Postoperative Nausea and Vomiting (PONV) and Subarachnoid Block, run by Rully Riyandika at 1 site in Indonesia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV), Subarachnoid Block, Spinal Anesthesia
- What is being tested?
- Haloperidol and Ondansetron 4mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Jan 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravenous Haloperidol and Ondansetron Administered Intraoperatively in Reducing the Incidence of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Regional Anesthesia With Subarachnoid Block (RA-SAB)
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.
Read the 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.
- Being tested
- Haloperidol, Ondansetron 4mg
- Keywords
- Haloperidol, Ondansetron, PONV, Regional Anesthesia, Subarachnoid Block, Spinal Anesthesia, Antiemetic Agents, Intraoperative Management, Postoperative Complications, Double-Blind Randomized Trial
- Medical subject headings
- Postoperative Nausea and Vomiting, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
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 4mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ondansetron 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Jan 2025
- Primary completion30 Apr 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and Vomiting (PONV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm, randomized, double-blind, parallel assignment study comparing haloperidol and ondansetron administered intraoperatively to prevent PONV in patients undergoing subarachnoid block anesthesia.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rully Riyandika
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rully Riyandika, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087925
- Sponsor's protocol ID
- HALO-ONDAN-PONV-RA-SAB
- Other IDs
- 1511/KEPK/USU/2024
- Acronym
- HALO-PONV
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes-including incidence of PONV, sedation, and patient characteristics (age, BMI, APFEL score)-will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Haloperidol and Ondansetron Administered Intraoperatively in Reducing the Incidence of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Regional Anesthesia With Subarachnoid Block (RA-SAB)
- ClinicalTrials.gov ID
- NCT07087925
- Acronym / sponsor ID
- HALO-PONV / HALO-ONDAN-PONV-RA-SAB
- Keywords
- Haloperidol, Ondansetron, PONV, Regional Anesthesia, Subarachnoid Block, Spinal Anesthesia, Antiemetic Agents, Intraoperative Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rully RiyandikaUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm, randomized, double-blind, parallel assignment study comparing haloperidol and ondansetron administered intraoperatively to prevent PONV in patients undergoing subarachnoid block anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Haloperidol IV Group | Experimental | Drug: HaloperidolParticipants 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. |
| Ondansetron IV Group | Active comparator | Drug: Ondansetron 4mgParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaloperidolA 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. | Drug | Haloperidol IV Group |
| Ondansetron 4mgA 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. | Drug | Ondansetron IV Group |
Primary outcome
Incidence of Postoperative Nausea and Vomiting (PONV) within 24 Hours After Surgery
Time frame: Within 24 hours postoperatively
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes-including incidence of PONV, sedation, and patient characteristics (age, BMI, APFEL score)-will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haloperidol and Ondansetron 4mg in people with Postoperative Nausea and Vomiting (PONV) and Subarachnoid Block, run by Rully Riyandika at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Nausea and Vomiting (PONV) within 24 Hours After Surgery (time frame: Within 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.