Gynecological DiseaseNCT01639599
Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients
A study testing Dexamethasone iv injection and Dexamethasone, haloperidol in people with Gynecological Disease, run by The Catholic University of Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Disease
- What is being tested?
- Dexamethasone iv injection and Dexamethasone, haloperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
About this study
Official title: Phase 4 Study of Optimal Dose of Haloperidol
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.
Read the 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).
- Conditions
- Gynecological Disease
- Being tested
- Dexamethasone iv injection, Dexamethasone, haloperidol
- Keywords
- non-smoker, female, IV PCA, patient-controlled analgesia
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone iv injectionDrug
Dexamethasone 5mg iv during anesthesia induction
Dexamethasone, haloperidolDrug
dexamethasone + haloperidol 1mg
Dexamethasone, haloperidolDrug
Active Comparator: dexamethasone + haloperidol 2mg
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | Placebo comparator | dexamethasone 5mg iv during anesthesia induction Receives: Drug: Dexamethasone iv injection |
| dexamethasone, haloperiol 1mg | Active comparator | dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia Receives: Drug: Dexamethasone, haloperidol |
| dexamethasone + haloperidol 2mg | Active comparator | dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia Receives: Drug: Dexamethasone, haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Nausea and Vomiting
incidence of nausea, vomiting and requirement for rescue antiemetics
Measured: postoperative 24 hours
Secondary outcomes (3)
Incidence of Extrapyramidal Symptoms
Measured: postoperative 24 hours
Incidence of Cardiac Arrhythmia
cardiac arrhythmia on continuous standard lead EKG monitoring
Measured: postoperative 2 hours
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)
Measured: postoperative 30, 60, 90, and 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- Y.E. Moon, MD, Principal investigator, associate proffesor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639599
- Sponsor's protocol ID
- haloperidol
- Status last verified
- Aug 2020
- First submitted
- 4 Jul 2012
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26152218
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Optimal Dose of Haloperidol
- ClinicalTrials.gov ID
- NCT01639599
- Acronym / sponsor ID
- haloperidol
- Conditions
- Gynecological Disease
- Keywords
- non-smoker, female, IV PCA, patient-controlled analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Placebo comparator | Drug: Dexamethasone iv injectiondexamethasone 5mg iv during anesthesia induction |
| dexamethasone, haloperiol 1mg | Active comparator | Drug: Dexamethasone, haloperidoldexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia |
| dexamethasone + haloperidol 2mg | Active comparator | Drug: Dexamethasone, haloperidoldexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone iv injectionDexamethasone 5mg iv during anesthesia induction | Drug | dexamethasone |
| Dexamethasone, haloperidoldexamethasone + haloperidol 1mg | Drug | dexamethasone, haloperiol 1mg |
| Dexamethasone, haloperidolActive Comparator: dexamethasone + haloperidol 2mg | Drug | dexamethasone + haloperidol 2mg |
Primary outcome
Incidence of Postoperative Nausea and Vomiting
Time frame: postoperative 24 hours
incidence of nausea, vomiting and requirement for rescue antiemetics
3 secondary outcomes
Incidence of Extrapyramidal Symptoms
Time frame: postoperative 24 hours
Incidence of Cardiac Arrhythmia
Time frame: postoperative 2 hours
Sedation Change in Recovery Room
Time frame: postoperative 30, 60, 90, and 120 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26152218Joo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Y.E. Moon, MD principal investigator
associate proffesor
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone iv injection and Dexamethasone, haloperidol in people with Gynecological Disease, run by The Catholic University of Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Nausea and Vomiting (time frame: postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01639599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.