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

Gynecological Disease Clinical Trial

Official title:

Phase 4 Study of Optimal Dose of Haloperidol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639599
• Other study ID #: haloperidol
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2020
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecological Disease

Intervention

Drug:
• Dexamethasone iv injection
Dexamethasone 5mg iv during anesthesia induction
• Dexamethasone, haloperidol
dexamethasone + haloperidol 1mg
• Dexamethasone, haloperidol
Active Comparator: dexamethasone + haloperidol 2mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Postoperative Nausea and Vomiting	incidence of nausea, vomiting and requirement for rescue antiemetics	postoperative 24 hours
Secondary	Incidence of Extrapyramidal Symptoms		postoperative 24 hours
Secondary	Incidence of Cardiac Arrhythmia	cardiac arrhythmia on continuous standard lead EKG monitoring	postoperative 2 hours
Secondary	Sedation Change in Recovery Room	measurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep)	postoperative 30, 60, 90, and 120 min