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Completed

NCT Number: NCT01639599

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone iv injection

Drug

Dexamethasone 5mg iv during anesthesia induction

Dexamethasone, haloperidol

Drug

dexamethasone + haloperidol 1mg

Primary outcomes

  1. Incidence of Postoperative Nausea and Vomiting

    Time frame: postoperative 24 hours

    incidence of nausea, vomiting and requirement for rescue antiemetics

Secondary outcomes

  1. Incidence of Extrapyramidal Symptoms

    Time frame: postoperative 24 hours

  2. Incidence of Cardiac Arrhythmia

    Time frame: postoperative 2 hours

    cardiac arrhythmia on continuous standard lead EKG monitoring

  3. Sedation Change in Recovery Room

    Time frame: postoperative 30, 60, 90, and 120 min

    measurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep)

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Phase 4 Study of Optimal Dose of Haloperidol

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 12, 2012
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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