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

NCT01639599 | Completed Results DMC

• 1 other identifier: haloperidol
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gynecological Disease

Keywords

non-smoker; female; IV PCA; patient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Nausea and Vomiting

  incidence of nausea, vomiting and requirement for rescue antiemetics

  postoperative 24 hours

Secondary Outcomes (3)

• Incidence of Extrapyramidal Symptoms

  postoperative 24 hours

• Incidence of Cardiac Arrhythmia

  postoperative 2 hours

• Sedation Change in Recovery Room

  postoperative 30, 60, 90, and 120 min

Study Arms (3)

dexamethasone

PLACEBO COMPARATOR

dexamethasone 5mg iv during anesthesia induction

Drug: Dexamethasone iv injection

dexamethasone, haloperiol 1mg

ACTIVE COMPARATOR

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

Drug: Dexamethasone, haloperidol

dexamethasone + haloperidol 2mg

ACTIVE COMPARATOR

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

Drug: Dexamethasone, haloperidol

Interventions

Dexamethasone iv injection DRUG

Dexamethasone 5mg iv during anesthesia induction

dexamethasone

Dexamethasone, haloperidol DRUG

dexamethasone + haloperidol 1mg

dexamethasone, haloperiol 1mg

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Catholic University of Korea: lead

Related Publications (1)

• Joo J, Park YG, Baek J, Moon YE. Haloperidol dose combined with dexamethasone for PONV prophylaxis in high-risk patients undergoing gynecological laparoscopic surgery: a prospective, randomized, double-blind, dose-response and placebo-controlled study. BMC Anesthesiol. 2015 Jul 8;15:99. doi: 10.1186/s12871-015-0081-1.

  PMID: 26152218 DERIVED

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Dexamethasone; Haloperidol

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Butyrophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Young Eun Moon
• Organization: Seoul St.Mary's Hospital,

0910momo@naver.com

822-2258-6163

Study Officials

• Y.E. Moon, MD

  associate proffesor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical associate professor

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 12, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: September 9, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share