Trial Outcomes & Findings for Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients (NCT NCT00345384)

Results Overview

To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

38 participants

Primary outcome timeframe

An average of 24 hours, up to 30 hours per patient

Results posted on

2016-02-08

Participant Flow

Participants will be recruited from the from the BUMC Operating Room schedule prior to their procedure. Informed consent will be obtained in a secure area. Recruitment will continue until goal reached.

Participants were required to be between the ages of 18-85 and receiving general anesthesia with an AMerican Society of Anesthesiologists score of three or less, and undergoing thoracotomy surgery. Liver and renal failure patients were excluded.

Participant milestones

Participant milestones
Measure	Normal Saline Blinded Normal saline infusion titrated as if study drug	Dexmedetomidine Received Dexmedetomidine for 24 hours
Overall Study STARTED	19	19
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Saline n=19 Participants Standard of care	Dexmedetomidine n=19 Participants titrated IV for 24 hours post ICU	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 12.8 • n=5 Participants	61 years STANDARD_DEVIATION 10.75 • n=7 Participants	60 years STANDARD_DEVIATION 11.75 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: An average of 24 hours, up to 30 hours per patient

Population: Participants completing the study were analyzed as per protocol

To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Patient group to receive placebo (saline).	Dexmedetomidine n=19 Participants Patient group to receive Dexmedetomidine.
Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. Morphine equivalency administered	49 IV morphine equivalency in mg Interval 14.0 to 84.0	29 IV morphine equivalency in mg Interval 3.0 to 55.0
Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. Adjusted for total time on study drug	54 IV morphine equivalency in mg Interval 17.0 to 91.0	35 IV morphine equivalency in mg Interval 7.0 to 63.0

SECONDARY outcome

Timeframe: Hours 6 to 16

Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Patient group to receive placebo (saline).	Dexmedetomidine n=19 Participants Patient group to receive Dexmedetomidine.
Measure the Amount of Respiratory Depression in Each Groups	45 mmHg Standard Deviation 9	42 mmHg Standard Deviation 8

Adverse Events

Normal Saline Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Study Drug Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Normal Saline Group n=19 participants at risk Normal saline infused at calculated rate as if it were study drug	Study Drug Group n=19 participants at risk Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU
Gastrointestinal disorders Nausea	36.8% 7/19 • Number of events 7 • 1 week from initiation of study drug. 0 serious adverse events were detected in patients enrolled in this study.	15.8% 3/19 • Number of events 3 • 1 week from initiation of study drug. 0 serious adverse events were detected in patients enrolled in this study.
Cardiac disorders Hypotension	5.3% 1/19 • Number of events 1 • 1 week from initiation of study drug. 0 serious adverse events were detected in patients enrolled in this study.	5.3% 1/19 • Number of events 1 • 1 week from initiation of study drug. 0 serious adverse events were detected in patients enrolled in this study.
Cardiac disorders Bradycardia	10.5% 2/19 • Number of events 2 • 1 week from initiation of study drug. 0 serious adverse events were detected in patients enrolled in this study.	0.00% 0/19 • 1 week from initiation of study drug. 0 serious adverse events were detected in patients enrolled in this study.
Cardiac disorders Tacycardia	15.8% 3/19 • Number of events 3 • 1 week from initiation of study drug. 0 serious adverse events were detected in patients enrolled in this study.	5.3% 1/19 • Number of events 1 • 1 week from initiation of study drug. 0 serious adverse events were detected in patients enrolled in this study.

Additional Information

President Baylor Research Institute

Baylor Research Institute

Phone: 214-820-3296

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place