Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk PONV patients receiving intravenous patient-controlled anesthesia (IV PCA) after gynecological laparoscopic surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06428084

Laparoscopic Cholecystectomy

COMPLETED PHASE2

Dexamethasone for Postoperative Nausea and Vomiting

NCT00825071

Postoperative Nausea and Vomiting

COMPLETED PHASE4

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

NCT07087925

Postoperative Nausea and Vomiting (PONV) Subarachnoid Block Spinal Anesthesia

COMPLETED NA

Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy

NCT00734929

Postoperative Nausea and Vomiting

COMPLETED PHASE4

Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant As PONV Prevention

NCT05773950

Postoperative Nausea and Vomiting Gynecologic Surgical Procedures Laparoscopy

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Female adults with three established PONV risk factors based on Apfel's score were randomised into one of three study groups. At the end of anaesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone during the induction of anaesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanaesthesia care unit (PACU).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecological Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dexamethasone

dexamethasone 5mg iv during anesthesia induction

Group Type PLACEBO_COMPARATOR

Dexamethasone iv injection

Intervention Type DRUG

Dexamethasone 5mg iv during anesthesia induction

dexamethasone, haloperiol 1mg

dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia

Group Type ACTIVE_COMPARATOR

Dexamethasone, haloperidol

Intervention Type DRUG

dexamethasone + haloperidol 1mg

dexamethasone + haloperidol 2mg

dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia

Group Type ACTIVE_COMPARATOR

Dexamethasone, haloperidol

Intervention Type DRUG

Active Comparator: dexamethasone + haloperidol 2mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone iv injection

Dexamethasone 5mg iv during anesthesia induction

Intervention Type DRUG

Dexamethasone, haloperidol

dexamethasone + haloperidol 1mg

Intervention Type DRUG

Dexamethasone, haloperidol

Active Comparator: dexamethasone + haloperidol 2mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA physical status I or II women
* Aged 20 65 years, and scheduled for gynecologic laparoscopic surgery and IV patient-controlled analgesia (PCA) for postoperative pain control.

Exclusion Criteria

* Known allergy or intolerance to the study drug
* History of cardiac arrhythmia
* Psychiatric illness
* Chronic treatment with a dopamine antagonist
* Use of opioids or steroids within one week of surgery
* Use of antiemetic within 24 hours before the study
* No ability to use the PCA device
* Gastrointestinal, renal, or hepatic disease
* Insulin-dependent diabetes or obesity with a body mass index \> 35 kg/m2.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes