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

Information source: The Catholic University of Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gynecological Disease

Intervention: Dexamethasone iv injection (Drug); Dexamethasone, haloperidol (Drug); Dexamethasone, haloperidol (Drug)

Phase: N/A

Status: Completed

Sponsored by: The Catholic University of Korea

Official(s) and/or principal investigator(s):
Y.E. Moon, MD, Principal Investigator, Affiliation: associate proffesor

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.

Clinical Details

Official title: Phase 4 Study of Optimal Dose of Haloperidol

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: incidence of postoperative nausea and vomiting

Secondary outcome:

incidence of extrapyramidal symptoms

incidence of cardiac arrhythmia

sedation change in recovery room

Detailed description: 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).

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: March 2012
Last updated: June 12, 2014

Page last updated: August 23, 2015

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