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

• Sponsor: The Catholic University of Korea (Other)
• Overall Status: Completed
• CT.gov ID: NCT01639599
• Collaborator: (none)
• Enrollment: 150
• Arms: 3
• Duration (Months): 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecological Disease	Drug: Dexamethasone iv injection; Drug: Dexamethasone, haloperidol; Drug: Dexamethasone, haloperidol	N/A

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

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Phase 4 Study of Optimal Dose of Haloperidol
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: dexamethasone dexamethasone 5mg iv during anesthesia induction	Drug: Dexamethasone iv injection; Dexamethasone 5mg iv during anesthesia induction
Active Comparator: dexamethasone, haloperiol 1mg dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia	Drug: Dexamethasone, haloperidol; dexamethasone + haloperidol 1mg
Active Comparator: dexamethasone + haloperidol 2mg dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia	Drug: Dexamethasone, haloperidol; Active Comparator: dexamethasone + haloperidol 2mg

Outcome Measures

Primary Outcome Measures

1. Incidence of Postoperative Nausea and Vomiting [postoperative 24 hours]

   incidence of nausea, vomiting and requirement for rescue antiemetics

Secondary Outcome Measures

1. Incidence of Extrapyramidal Symptoms [postoperative 24 hours]

2. Incidence of Cardiac Arrhythmia [postoperative 2 hours]

   cardiac arrhythmia on continuous standard lead EKG monitoring

3. Sedation Change in Recovery Room [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The Catholic University of Korea

Investigators

• Principal Investigator: Y.E. Moon, MD, associate proffesor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young Eun Moon, clinical associate professor, The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT01639599
• Other Study ID Numbers: haloperidol
• First Posted: Jul 12, 2012
• Last Update Posted: Sep 9, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Young Eun Moon, clinical associate professor, The Catholic University of Korea: non-smoker; female; IV PCA; patient-controlled analgesia
• Additional relevant MeSH terms: Dexamethasone; Dexamethasone acetate; Haloperidol; Haloperidol decanoate; BB 1101

Study Results

Participant Flow

Arm/Group Title	Dexamethasone	Dexamethasone, Haloperiol 1mg	Dexamethasone + Haloperidol 2mg
Arm/Group Description	dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction	dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg	dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
Period Title: Overall Study
STARTED	50	50	50
COMPLETED	50	49	50
NOT COMPLETED	0	1	0

Baseline Characteristics

Arm/Group Title	Dexamethasone	Dexamethasone, Haloperiol 1mg	Dexamethasone + Haloperidol 2mg	Total
Arm/Group Description	dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction	dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg	dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg	Total of all reporting groups
Overall Participants	50	49	50	149
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	50 100%	49 100%	50 100%	149 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	50 100%	49 100%	50 100%	149 100%
Male	0 0%	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
South Korea	50 100%	49 100%	50 100%	149 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Postoperative Nausea and Vomiting
Description	incidence of nausea, vomiting and requirement for rescue antiemetics
Time Frame	postoperative 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone	Dexamethasone, Haloperiol 1mg	Dexamethasone + Haloperidol 2mg
Arm/Group Description	dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction	dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg	dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
Measure Participants	50	49	50
Number [participants]	21 42%	11 22.4%	10 20%

2. Secondary Outcome

Title	Incidence of Extrapyramidal Symptoms
Time Frame	postoperative 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone	Dexamethasone, Haloperiol 1mg	Dexamethasone + Haloperidol 2mg
Arm/Group Description	dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction	dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg	dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
Measure Participants	50	49	50
Number [participants]	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Incidence of Cardiac Arrhythmia
Description	cardiac arrhythmia on continuous standard lead EKG monitoring
Time Frame	postoperative 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone	Dexamethasone, Haloperiol 1mg	Dexamethasone + Haloperidol 2mg
Arm/Group Description	dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction	dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg	dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
Measure Participants	50	49	50
Count of Participants [Participants]	0 0%	0 0%	0 0%

4. Secondary Outcome

Title	Sedation Change in Recovery Room
Description	measurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep)
Time Frame	postoperative 30, 60, 90, and 120 min

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone	Dexamethasone, Haloperiol 1mg	Dexamethasone + Haloperidol 2mg
Arm/Group Description	dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction	dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg	dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
Measure Participants	50	49	50
postoperative 30 min	4.6 (1.3)	4.7 (1.0)	5.5 (1.1)
postoperative 60 min	4.4 (1.3)	4.4 (1.0)	5.0 (1.0)
postoperative 90 min	3.5 (1.4)	4.0 (1.2)	4.7 (0.9)
postoperative 120 min	3.0 (1.0)	3.2 (1.1)	4.3 (1.3)

Adverse Events

Arm/Group Title	Dexamethasone		Dexamethasone, Haloperiol 1mg		Dexamethasone + Haloperidol 2mg
Arm/Group Description	dexamethasone 5mg iv during anesthesia induction Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction		dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg		dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
All Cause Mortality
	Dexamethasone		Dexamethasone, Haloperiol 1mg		Dexamethasone + Haloperidol 2mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexamethasone		Dexamethasone, Haloperiol 1mg		Dexamethasone + Haloperidol 2mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/49 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone		Dexamethasone, Haloperiol 1mg		Dexamethasone + Haloperidol 2mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/49 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.