Trial Outcomes & Findings for Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion (NCT NCT00808665)
NCT ID: NCT00808665
Last Updated: 2018-05-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
68 participants
Primary outcome timeframe
Start of study drug to time to reach fitness for discharge from hospital (about 3 to 5 days)
Results posted on
2018-05-25
Participant Flow
68 participants were assessed for eligibility but 5 failed Inclusion and Exclusion criteria and were not randomized
Participant milestones
| Measure |
Dexmedetomidine
At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
Saline
Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
Medication Started
|
30
|
32
|
|
Overall Study
Completed Intra-operative Dose
|
26
|
32
|
|
Overall Study
Completed Post Operative Doses
|
25
|
29
|
|
Overall Study
COMPLETED
|
25
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Dexmedetomidine
At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
Saline
Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
only required minimally invasive surgery
|
1
|
0
|
|
Overall Study
surgery cancelled
|
1
|
0
|
|
Overall Study
required an additional procedure
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Medication stopped by resident
|
0
|
1
|
Baseline Characteristics
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=31 Participants
At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
Saline
n=32 Participants
Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
58 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of study drug to time to reach fitness for discharge from hospital (about 3 to 5 days)Population: analysis done on the 54 participants that received the entire course of Dexmedetomidine or placebo.
Outcome measures
| Measure |
Dexmedetomidine
n=25 Participants
At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
Saline
n=29 Participants
Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
|---|---|---|
|
Time Required After Surgery to Reach Fitness for Discharge From Hospital
|
3.2 days
Interval 2.0 to 4.0
|
3.2 days
Interval 2.2 to 4.6
|
Adverse Events
Dexmedetomidine
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Saline
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexmedetomidine
n=30 participants at risk
At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
Saline
n=32 participants at risk
Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrthymia
|
3.3%
1/30 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
3.1%
1/32 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/30 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
3.1%
1/32 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Nervous system disorders
Stroke
|
0.00%
0/30 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
3.1%
1/32 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/30 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
3.1%
1/32 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
Other adverse events
| Measure |
Dexmedetomidine
n=30 participants at risk
At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
Saline
n=32 participants at risk
Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
|
|---|---|---|
|
Cardiac disorders
hypotension
|
20.0%
6/30 • Number of events 6 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
15.6%
5/32 • Number of events 5 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Surgical and medical procedures
Bleeding
|
30.0%
9/30 • Number of events 9 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
18.8%
6/32 • Number of events 6 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Nervous system disorders
Delirium
|
6.7%
2/30 • Number of events 2 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
3.1%
1/32 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Surgical and medical procedures
Wound Infection
|
6.7%
2/30 • Number of events 2 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
3.1%
1/32 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Surgical and medical procedures
Return the the Operating Room
|
10.0%
3/30 • Number of events 3 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
0.00%
0/32 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Surgical and medical procedures
Device/Hardware Failure
|
6.7%
2/30 • Number of events 2 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
0.00%
0/32 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Cardiac disorders
Chest Pain
|
3.3%
1/30 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
0.00%
0/32 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Nervous system disorders
Prolonged Memory loss
|
0.00%
0/30 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
3.1%
1/32 • Number of events 1 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
|
Cardiac disorders
EKG Changes
|
76.7%
23/30 • Number of events 23 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
81.2%
26/32 • Number of events 26 • from study drug start to hospital discharge ( about 3-5 days)
Participants that received any amount of study drug ( "Medication Started" Milestone in participant flow) were included in Adverse Event Reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place