Trial · NCT02004613

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

NCT02004613, Phase 4, Completed, The Cleveland Clinic; results first posted 2021-04-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery. Trials, record NCT02004613. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02004613

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
NCT number: NCT02004613
Status: Completed
Phases: Phase 4
Enrollment: 798 participants, actual
Lead sponsor: The Cleveland Clinic
Conditions: Heart Disease
Interventions: Dexmedetomidine, Placebo
First posted: 2013-12-09
Last updated: 2021-04-06
Results first posted: 2021-04-06

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With Atrial Arrhythmia	From the end of surgery to postoperative day 5	The occurrence of postoperative atrial arrhythmias
Primary	Number of Patients With Delirium	From the end of surgery to postoperative day 5	The occurrence of postoperative delirium
Secondary	Number of Patients With Acute Kidney Injury	From the end of surgery to postoperative day 5	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.
Secondary	Number of Patients With Incisional Pain	90 days after surgery	Patients were evaluated at 90 days by modified Brief Pain Inventory.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With Atrial Arrhythmia	From the end of surgery to postoperative day 5	2 patients had no Atrial Arrhythmia data.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Patients With Delirium	From the end of surgery to postoperative day 5	Delirium data is not available in 18 patients.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Acute Kidney Injury	From the end of surgery to postoperative day 5	Acute kidney injury data is not available in 16 patients.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Incisional Pain	90 days after surgery	Incisional pain at 90 days is not available in 205 patients.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Patients With Atrial Arrhythmia	Dexmedetomidine		121	Participants
Number of Patients With Atrial Arrhythmia	Placebo		134	Participants
Number of Patients With Delirium	Dexmedetomidine		67	Participants
Number of Patients With Delirium	Placebo		46	Participants
Number of Patients With Acute Kidney Injury	Dexmedetomidine	No risk	348	Participants
Number of Patients With Acute Kidney Injury	Placebo	No risk	359	Participants
Number of Patients With Acute Kidney Injury	Dexmedetomidine	stage1	33	Participants
Number of Patients With Acute Kidney Injury	Placebo	stage1	29	Participants
Number of Patients With Acute Kidney Injury	Dexmedetomidine	Stage2	4	Participants
Number of Patients With Acute Kidney Injury	Placebo	Stage2	0	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dexmedetomidine	400
Overall Study	STARTED	Placebo	398
Overall Study	COMPLETED	Dexmedetomidine	398
Overall Study	COMPLETED	Placebo	396
Overall Study	NOT COMPLETED	Dexmedetomidine	2
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Clinically important bradycardia	Cardiac disorders	Dexmedetomidine	36	394
other	Clinically important bradycardia	Cardiac disorders	Placebo	45	390
other	Clinically important hypotension	Blood and lymphatic system disorders	Dexmedetomidine	224	394
other	Clinically important hypotension	Blood and lymphatic system disorders	Placebo	140	390
serious	Hemorrhage	Blood and lymphatic system disorders	Dexmedetomidine	4	394
serious	Hemorrhage	Blood and lymphatic system disorders	Placebo	3	390
serious	asystol	Cardiac disorders	Dexmedetomidine	1	394
serious	asystol	Cardiac disorders	Placebo	1	390
serious	heart failure	Cardiac disorders	Dexmedetomidine	1	394
serious	heart failure	Cardiac disorders	Placebo	0	390

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dexmedetomidine	1	394
Total, all-cause mortality	Placebo	1	390
Total, other adverse events	Dexmedetomidine	234	394
Total, other adverse events	Placebo	154	390
Total, serious adverse events	Dexmedetomidine	21	394
Total, serious adverse events	Placebo	8	390

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32682483	DERIVED	PubMed
36894011	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dexmedetomidine vs Placebo: Number of Patients With Incisional Pain	Trial comparisons
Dexmedetomidine vs Placebo: Number of Patients With Atrial Arrhythmia	Trial comparisons
Dexmedetomidine vs Placebo: Number of Patients With Delirium	Trial comparisons
Dexmedetomidine vs Placebo: deaths from any cause	Trial comparisons
Dexmedetomidine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02004613

GET https://conductscience.org/api/trials/v1/NCT02004613/events?page=2

API reference For AI assistants