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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)

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ClinicalTrials.gov Identifier: NCT02004613
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Alparslan Turan, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Investigator);   Primary Purpose: Treatment
Condition Heart Disease
Interventions Drug: Dexmedetomidine
Drug: Placebo
Enrollment 798
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description

Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine

normal saline administration matching dexmedetomidine rate of infusion.

Placebo: Normal saline administration matching dexmedetomidine rate of infusion

Period Title: Overall Study
Started 400 398
Completed 398 396
Not Completed 2 2
Arm/Group Title Dexmedetomidine Placebo Total
Hide Arm/Group Description

Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine

normal saline administration matching dexmedetomidine rate of infusion.

Placebo: Normal saline administration matching dexmedetomidine rate of infusion

Total of all reporting groups
Overall Number of Baseline Participants 398 396 794
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 396 participants 394 participants 790 participants
63  (11) 62  (12) 63  (12)
[1]
Measure Analysis Population Description: Only reported the mean and standard deviation for each group. Age is not available for 4 patients.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 394 participants 790 participants
Female
132
  33.3%
111
  28.2%
243
  30.8%
Male
264
  66.7%
283
  71.8%
547
  69.2%
[1]
Measure Analysis Population Description: 4 patients sex data were not availiable.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 395 participants 394 participants 789 participants
white
365
  92.4%
363
  92.1%
728
  92.3%
not white
30
   7.6%
31
   7.9%
61
   7.7%
[1]
Measure Analysis Population Description: 5 patients didn't had availiable race data.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 398 participants 396 participants 794 participants
398 396 794
Modified Brief Pain Inventory   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Overall Severity (any) Number Analyzed 374 participants 376 participants 750 participants
95
  25.4%
89
  23.7%
184
  24.5%
Pain interference (any) Number Analyzed 398 participants 396 participants 794 participants
85
  21.4%
83
  21.0%
168
  21.2%
[1]
Measure Analysis Population Description: 44 patients' baseline MBPI information was not available. Any overall severity means any pain in the last 24 hours. Any pain inference means any pain that interfering with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours.
1.Primary Outcome
Title Number of Patients With Atrial Arrhythmia
Hide Description The occurrence of postoperative atrial arrhythmias
Time Frame From the end of surgery to postoperative day 5
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients had no Atrial Arrhythmia data.
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine

normal saline administration matching dexmedetomidine rate of infusion.

Placebo: Normal saline administration matching dexmedetomidine rate of infusion

Overall Number of Participants Analyzed 397 395
Measure Type: Count of Participants
Unit of Measure: Participants
121
  30.5%
134
  33.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexmedetomidine, Placebo
Comments Hypothesis: dexmedetomidine would reduce the incidence of postoperative atrial arrhythmias.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.91
Confidence Interval (2-Sided) 97.8%
0.72 to 1.15
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Patients With Delirium
Hide Description The occurrence of postoperative delirium
Time Frame From the end of surgery to postoperative day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Delirium data is not available in 18 patients.
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine

normal saline administration matching dexmedetomidine rate of infusion.

Placebo: Normal saline administration matching dexmedetomidine rate of infusion

Overall Number of Participants Analyzed 389 387
Measure Type: Count of Participants
Unit of Measure: Participants
67
  17.2%
46
  11.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexmedetomidine, Placebo
Comments hypothesis: Dexmedetomidine may reduce the incidence of postoperative delirium.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.48
Confidence Interval (2-Sided) 97.8%
0.99 to 2.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients With Acute Kidney Injury
Hide Description Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function.
Time Frame From the end of surgery to postoperative day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Acute kidney injury data is not available in 16 patients.
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine

normal saline administration matching dexmedetomidine rate of infusion.

Placebo: Normal saline administration matching dexmedetomidine rate of infusion

Overall Number of Participants Analyzed 389 389
Measure Type: Count of Participants
Unit of Measure: Participants
No risk
348
  89.5%
359
  92.3%
stage1
33
   8.5%
29
   7.5%
Stage2
4
   1.0%
0
   0.0%
Stage3
4
   1.0%
1
   0.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexmedetomidine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.40
Confidence Interval (2-Sided) 97.5%
0.84 to 2.34
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients With Incisional Pain
Hide Description Patients were evaluated at 90 days by modified Brief Pain Inventory.
Time Frame 90 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Incisional pain at 90 days is not available in 205 patients.
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description:

Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine

normal saline administration matching dexmedetomidine rate of infusion.

Placebo: Normal saline administration matching dexmedetomidine rate of infusion

Overall Number of Participants Analyzed 289 300
Measure Type: Count of Participants
Unit of Measure: Participants
79
  27.3%
93
  31.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexmedetomidine, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.87
Confidence Interval (2-Sided) 97.5%
0.65 to 1.16
Estimation Comments [Not Specified]
Time Frame 5 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexmedetomidine Placebo
Hide Arm/Group Description

Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine

normal saline administration matching dexmedetomidine rate of infusion.

Placebo: Normal saline administration matching dexmedetomidine rate of infusion

All-Cause Mortality
Dexmedetomidine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/394 (0.25%)   1/390 (0.26%) 
Hide Serious Adverse Events
Dexmedetomidine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/394 (5.33%)   8/390 (2.05%) 
Blood and lymphatic system disorders     
Hemorrhage *  4/394 (1.02%)  3/390 (0.77%) 
Cardiac disorders     
asystol *  1/394 (0.25%)  1/390 (0.26%) 
heart failure *  1/394 (0.25%)  0/390 (0.00%) 
re-intervention * [1]  0/394 (0.00%)  1/390 (0.26%) 
Cardiogenic shock *  1/394 (0.25%)  0/390 (0.00%) 
Myocardial infarction * [2]  1/394 (0.25%)  0/390 (0.00%) 
Pericardial effusion *  1/394 (0.25%)  0/390 (0.00%) 
Infections and infestations     
infection *  2/394 (0.51%)  0/390 (0.00%) 
Nervous system disorders     
seizure *  0/394 (0.00%)  1/390 (0.26%) 
stroke *  3/394 (0.76%)  1/390 (0.26%) 
Transient Ischemic attack *  1/394 (0.25%)  0/390 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis *  2/394 (0.51%)  0/390 (0.00%) 
Hypoxemia *  1/394 (0.25%)  0/390 (0.00%) 
Pneumothorax *  1/394 (0.25%)  1/390 (0.26%) 
Pulmonary embolism *  1/394 (0.25%)  0/390 (0.00%) 
Vascular disorders     
hypotension *  1/394 (0.25%)  0/390 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
The patient went back to the operation room for redo complex mitral valve repair with plication
[2]
Elevated troponin postoperatively
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dexmedetomidine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   234/394 (59.39%)   154/390 (39.49%) 
Blood and lymphatic system disorders     
Clinically important hypotension *  224/394 (56.85%)  140/390 (35.90%) 
Cardiac disorders     
Clinically important bradycardia *  36/394 (9.14%)  45/390 (11.54%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alparslan Turan
Organization: Cleveland Clinic Foundation
Phone: 216-445-9857
EMail: turana@ccf.org
Layout table for additonal information
Responsible Party: Alparslan Turan, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02004613    
Other Study ID Numbers: 12-1379
First Submitted: August 1, 2013
First Posted: December 9, 2013
Results First Submitted: December 18, 2020
Results First Posted: April 6, 2021
Last Update Posted: April 6, 2021