Trial Outcomes & Findings for Guanfacine for PONV and Pain After Sinus Surgery (NCT NCT02882854)
NCT ID: NCT02882854
Last Updated: 2019-01-03
Results Overview
Comparison of PONV Score of assessments done at 15 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
15 minutes after arriving in PACU
Results posted on
2019-01-03
Participant Flow
Participant milestones
| Measure |
Guanfacine
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
44
|
|
Overall Study
COMPLETED
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Guanfacine
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Guanfacine
n=39 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=41 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=39 Participants
|
34 Participants
n=41 Participants
|
68 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=80 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 16.9 • n=39 Participants
|
48.7 years
STANDARD_DEVIATION 15.4 • n=41 Participants
|
45.3 years
STANDARD_DEVIATION 16.5 • n=80 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
40 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
40 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
39 participants
n=39 Participants
|
41 participants
n=41 Participants
|
80 participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after arriving in PACUPopulation: 15 minute nVRS datapoint was not available for 2 participants in the Placebo group
Comparison of PONV Score of assessments done at 15 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Outcome measures
| Measure |
Guanfacine
n=39 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=39 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
None (nVRS 0)
|
35 Participants
|
33 Participants
|
|
Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Mild (nVRS 1-5)
|
1 Participants
|
2 Participants
|
|
Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Moderate/Severe (nVRS 6-10)
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after arriving in PACUComparison of PONV Score of assessments done at 30 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Outcome measures
| Measure |
Guanfacine
n=39 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=41 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Mild (nVRS 1-5)
|
4 Participants
|
5 Participants
|
|
Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
None (nVRS 0)
|
34 Participants
|
34 Participants
|
|
Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Moderate/Severe (nVRS 6-10)
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 60 minutes after arriving in PACUPopulation: nVRS data was not available for 1 participant in the Guanfacine group
Comparison of PONV Score of assessments done at 60 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Outcome measures
| Measure |
Guanfacine
n=38 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=41 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
None (nVRS 0)
|
33 Participants
|
35 Participants
|
|
Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Mild (nVRS 1-5)
|
2 Participants
|
5 Participants
|
|
Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Moderate/Severe (nVRS 6-10)
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 24 hours post opPopulation: Only 70 patients (32 in guanfacine arm; 38 in placebo arm) responded to follow-up phone call and provided PONV data at the 24 hour timepoint.
PONV assessed using nVRS at 24 hours postop when 0 is no nausea and 10 is worst nausea.
Outcome measures
| Measure |
Guanfacine
n=32 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=38 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)
|
0.00 score on a scale
Interval 0.0 to 0.25
|
0.00 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 15, 30, 60 minutes after arriving in PACUPopulation: Data unavailable for 2 participants in the placebo group at 15 minute time point, 1 participant in the placebo group at the 30 minute time point,
Maximum postoperative pain assessment assessed in PACU at 15, 30 and 60 minutes after PACU arrival using VAS when 0 is no pain and 10 is worst pain
Outcome measures
| Measure |
Guanfacine
n=39 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=41 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
15 minutes after PACU admission · Moderate/Severe (Pain nVRS 6-10)
|
8 Participants
|
10 Participants
|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
30 minutes after PACU admission · None (Pain nVRS 0)
|
18 Participants
|
20 Participants
|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
30 minutes after PACU admission · Mild (Pain nVRS 1-5)
|
7 Participants
|
6 Participants
|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
60 minutes after PACU admission · None (Pain nVRS 0)
|
12 Participants
|
16 Participants
|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
15 minutes after PACU admission · None (Pain nVRS 0)
|
31 Participants
|
24 Participants
|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
15 minutes after PACU admission · Mild (Pain nVRS 1-5)
|
0 Participants
|
5 Participants
|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
30 minutes after PACU admission · Moderate/Severe (Pain nVRS 6-10)
|
14 Participants
|
14 Participants
|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
60 minutes after PACU admission · Mild (Pain nVRS 1-5)
|
6 Participants
|
13 Participants
|
|
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
60 minutes after PACU admission · Moderate/Severe (Pain nVRS 6-10)
|
21 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 hours postopPopulation: Based on only 71 participants to post operative questionnaire.
Postoperative pain assessment using VAS at 24 hours postop when 0 is no pain and 10 is worst pain
Outcome measures
| Measure |
Guanfacine
n=33 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=38 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
|
3 score on a scale
Interval 3.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Time frame between arrival and discharge in PACU, approximately 90 minutesPopulation: Data was not available for 1 participant in the placebo group.
Total narcotic requirement in PACU tallied in morphine equivalents during PACU stay
Outcome measures
| Measure |
Guanfacine
n=39 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=40 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Total Narcotic Requirement in PACU
|
8.75 morphine equivalents
Interval 4.38 to 18.88
|
7.50 morphine equivalents
Interval 0.0 to 16.25
|
SECONDARY outcome
Timeframe: Time frame between arrival and discharge in PACU, approximately 90 minutesPopulation: Data missing for1 participants in the placebo group and 1 participant in the Guanfacine group.
Outcome measures
| Measure |
Guanfacine
n=38 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=40 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
Number of Doses of PONV Treatment Administered in PACU
Two doses
|
4 Participants
|
3 Participants
|
|
Number of Doses of PONV Treatment Administered in PACU
Zero doses
|
26 Participants
|
32 Participants
|
|
Number of Doses of PONV Treatment Administered in PACU
One dose
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Time frame between arrival and discharge in PACU, approximately 90 minutesOutcome measures
| Measure |
Guanfacine
n=39 Participants
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine: Patients will receive 1 mg of guanfacine to take orally.
|
Placebo
n=41 Participants
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo: Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
|
|---|---|---|
|
PACU Length of Stay in Minutes
|
128 minutes
Interval 95.0 to 169.5
|
110 minutes
Interval 87.0 to 155.0
|
Adverse Events
Guanfacine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Stephen Harvey, MD
Vanderbilt University Medical Center
Phone: (615) 936-3198
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place