Trial Outcomes & Findings for Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery (NCT NCT01973452)
NCT ID: NCT01973452
Last Updated: 2024-02-20
Results Overview
total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
333 participants
Primary outcome timeframe
up to 4 hours
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine
continuous infusion of 0.4 mcg/kg/hr
Dexmedetomidine
|
Placebo
continuous infusion of 0.4 mcg/kg/hr
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
166
|
|
Overall Study
COMPLETED
|
148
|
152
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
Reasons for withdrawal
| Measure |
Dexmedetomidine
continuous infusion of 0.4 mcg/kg/hr
Dexmedetomidine
|
Placebo
continuous infusion of 0.4 mcg/kg/hr
Placebo
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
|
Overall Study
Ineligible
|
1
|
1
|
|
Overall Study
Surgery canceled by participant
|
5
|
3
|
Baseline Characteristics
Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=148 Participants
continuous infusion of 0.4 mcg/kg/hr
Dexmedetomidine
|
Placebo
n=152 Participants
continuous infusion of 0.4 mcg/kg/hr
Placebo
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
65 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
148 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 hourstotal opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours
Outcome measures
| Measure |
Dexmedetomidine
n=148 Participants
continuous infusion of 0.4 mcg/kg/hr
Dexmedetomidine
|
Placebo
n=152 Participants
continuous infusion of 0.4 mcg/kg/hr
Placebo
|
|---|---|---|
|
Total Opioid Administered
|
4.0 Morphine Milligram Equivalents
Interval 0.0 to 12.0
|
6.0 Morphine Milligram Equivalents
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: up to 24 hoursas measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). In the Pain Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
Outcome measures
| Measure |
Dexmedetomidine
n=148 Participants
continuous infusion of 0.4 mcg/kg/hr
Dexmedetomidine
|
Placebo
n=152 Participants
continuous infusion of 0.4 mcg/kg/hr
Placebo
|
|---|---|---|
|
Improves Analgesia
|
4.0 score on a scale
Interval 2.7 to 5.0
|
4.0 score on a scale
Interval 2.8 to 5.0
|
SECONDARY outcome
Timeframe: up to 24 hoursas measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively.
Outcome measures
| Measure |
Dexmedetomidine
n=148 Participants
continuous infusion of 0.4 mcg/kg/hr
Dexmedetomidine
|
Placebo
n=152 Participants
continuous infusion of 0.4 mcg/kg/hr
Placebo
|
|---|---|---|
|
Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation
Participants with recorded nausea
|
113 Participants
|
110 Participants
|
|
Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation
Participants without recorded nausea
|
35 Participants
|
42 Participants
|
Adverse Events
Dexmedetomidine
Serious events: 5 serious events
Other events: 0 other events
Deaths: 33 deaths
Placebo
Serious events: 8 serious events
Other events: 0 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
Dexmedetomidine
n=148 participants at risk
continuous infusion of 0.4 mcg/kg/hr
Dexmedetomidine
|
Placebo
n=152 participants at risk
continuous infusion of 0.4 mcg/kg/hr
Placebo
|
|---|---|---|
|
General disorders
Fever
|
1.4%
2/148 • Up to 24 hours
|
0.00%
0/152 • Up to 24 hours
|
|
Infections and infestations
Lung infection
|
0.00%
0/148 • Up to 24 hours
|
1.3%
2/152 • Up to 24 hours
|
|
Injury, poisoning and procedural complications
Intraoperative splenic injury
|
0.00%
0/148 • Up to 24 hours
|
0.66%
1/152 • Up to 24 hours
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/148 • Up to 24 hours
|
0.66%
1/152 • Up to 24 hours
|
|
Psychiatric disorders
Delirium
|
0.00%
0/148 • Up to 24 hours
|
0.66%
1/152 • Up to 24 hours
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.68%
1/148 • Up to 24 hours
|
0.00%
0/152 • Up to 24 hours
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/148 • Up to 24 hours
|
0.66%
1/152 • Up to 24 hours
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.68%
1/148 • Up to 24 hours
|
0.66%
1/152 • Up to 24 hours
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.68%
1/148 • Up to 24 hours
|
0.66%
1/152 • Up to 24 hours
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alessia Pedoto, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-6840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place