Trial Outcomes & Findings for Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients (NCT NCT01639599)
NCT ID: NCT01639599
Last Updated: 2020-09-09
Results Overview
incidence of nausea, vomiting and requirement for rescue antiemetics
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
postoperative 24 hours
Results posted on
2020-09-09
Participant Flow
Participant milestones
| Measure |
Dexamethasone
dexamethasone 5mg iv during anesthesia induction
Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction
|
Dexamethasone, Haloperiol 1mg
dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg
|
Dexamethasone + Haloperidol 2mg
dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dexamethasone
n=50 Participants
dexamethasone 5mg iv during anesthesia induction
Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction
|
Dexamethasone, Haloperiol 1mg
n=49 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg
|
Dexamethasone + Haloperidol 2mg
n=50 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=149 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=50 Participants
|
49 Participants
n=49 Participants
|
50 Participants
n=50 Participants
|
149 Participants
n=149 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=149 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=50 Participants
|
49 Participants
n=49 Participants
|
50 Participants
n=50 Participants
|
149 Participants
n=149 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=149 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
50 participants
n=50 Participants
|
49 participants
n=49 Participants
|
50 participants
n=50 Participants
|
149 participants
n=149 Participants
|
PRIMARY outcome
Timeframe: postoperative 24 hoursincidence of nausea, vomiting and requirement for rescue antiemetics
Outcome measures
| Measure |
Dexamethasone
n=50 Participants
dexamethasone 5mg iv during anesthesia induction
Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction
|
Dexamethasone, Haloperiol 1mg
n=49 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg
|
Dexamethasone + Haloperidol 2mg
n=50 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
|
|---|---|---|---|
|
Incidence of Postoperative Nausea and Vomiting
|
21 participants
|
11 participants
|
10 participants
|
SECONDARY outcome
Timeframe: postoperative 24 hoursOutcome measures
| Measure |
Dexamethasone
n=50 Participants
dexamethasone 5mg iv during anesthesia induction
Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction
|
Dexamethasone, Haloperiol 1mg
n=49 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg
|
Dexamethasone + Haloperidol 2mg
n=50 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
|
|---|---|---|---|
|
Incidence of Extrapyramidal Symptoms
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: postoperative 2 hourscardiac arrhythmia on continuous standard lead EKG monitoring
Outcome measures
| Measure |
Dexamethasone
n=50 Participants
dexamethasone 5mg iv during anesthesia induction
Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction
|
Dexamethasone, Haloperiol 1mg
n=49 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg
|
Dexamethasone + Haloperidol 2mg
n=50 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
|
|---|---|---|---|
|
Incidence of Cardiac Arrhythmia
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: postoperative 30, 60, 90, and 120 minmeasurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep)
Outcome measures
| Measure |
Dexamethasone
n=50 Participants
dexamethasone 5mg iv during anesthesia induction
Dexamethasone iv injection: Dexamethasone 5mg iv during anesthesia induction
|
Dexamethasone, Haloperiol 1mg
n=49 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: dexamethasone + haloperidol 1mg
|
Dexamethasone + Haloperidol 2mg
n=50 Participants
dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia
Dexamethasone, haloperidol: Active Comparator: dexamethasone + haloperidol 2mg
|
|---|---|---|---|
|
Sedation Change in Recovery Room
postoperative 30 min
|
4.6 score on a scale
Standard Deviation 1.3
|
4.7 score on a scale
Standard Deviation 1.0
|
5.5 score on a scale
Standard Deviation 1.1
|
|
Sedation Change in Recovery Room
postoperative 60 min
|
4.4 score on a scale
Standard Deviation 1.3
|
4.4 score on a scale
Standard Deviation 1.0
|
5.0 score on a scale
Standard Deviation 1.0
|
|
Sedation Change in Recovery Room
postoperative 90 min
|
3.5 score on a scale
Standard Deviation 1.4
|
4.0 score on a scale
Standard Deviation 1.2
|
4.7 score on a scale
Standard Deviation 0.9
|
|
Sedation Change in Recovery Room
postoperative 120 min
|
3.0 score on a scale
Standard Deviation 1.0
|
3.2 score on a scale
Standard Deviation 1.1
|
4.3 score on a scale
Standard Deviation 1.3
|
Adverse Events
Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone, Haloperiol 1mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone + Haloperidol 2mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place