Trial · NCT02856594
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep
NCT02856594, Phase 2, Phase 3, Completed, Massachusetts General Hospital; results first posted 2023-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep. Trials, record NCT02856594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02856594
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep
- NCT number
- NCT02856594
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 469 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Postoperative Delirium, Sleep, Anesthesia
- Interventions
- Dexmedetomidine, Placebo
- First posted
- 2016-08-05
- Last updated
- 2026-09-01
- Results first posted
- 2023-03-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Delirium | Post operative day 1 (24 hours) | The number of patients with delirium is reported using the Confusion Assessment Method. |
| Secondary | ICU Delirium/Coma-free Days | Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5 | Confusion Assessment Method |
| Secondary | Severity of Delirium | Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5 | Confusion Assessment Method (CAM): Minimum Score=0, Maximum Score=19, Higher Scores: indicate increased severity of delirium |
| Secondary | Cumulative 30-day, 90-day, and 180-day Mortality | Up to postoperative day 180 (6 months) | The number of cumulative deaths occurring at 30-days, 90-days, and 180-days |
| Secondary | Postoperative Cognitive Status | 30 days, 90 days, and 180 days postoperatively | Telephone Montreal Cognitive Assessment (tMoCA): Minimum Score=0, Maximum Score=22, Higher Scores: indicate better cognitive function |
| Secondary | Postoperative Health Related Quality of Life | 30 days, 90 days, and 180 days postoperatively | This included the PROMIS Global Health SF V.1.1, PROMIS Physical Function SF 8b V.1.2, PROMIS Pain Interference SF 8a V.1.0, PROMIS Applied Cognition Abilities SF 8a V.1.0, and PROMIS Sleep Disturbance SF 4A V.1.0, respectively. Scores from each assessment were converted to a T-score for analysis with a mean of 50 and a standard deviation of 10, with lower scores on the PROMIS Pain Interference SF and PROMIS Sleep Disturbance SF considered better, whereas higher scores on all other assessments were considered better. |
| Secondary | Blood Delirium Biomarkers | perioperative | Blood samples will be taken including whole blood, serum, TruCulture, and PAXgene to assess proteins, DNA, and RNA. |
| Secondary | EEG Delirium Biomarkers | intraoperative | EEG alpha power will be analyzed for association with delirium. |
| Other | Length of Hospital Stay | From postoperative day 0 until date of hospital discharge, a median of 6 days | Medical Record Review |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Delirium | Post operative day 1 (24 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ICU Delirium/Coma-free Days | Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severity of Delirium | Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5 | score on a scale | MEDIAN | |
| SECONDARY | 30-day, 90-day, and 180-day Mortality | Up to postoperative day 180 (6 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Postoperative Cognitive Status | 30 days, 90 days, and 180 days postoperatively | score on a scale | MEDIAN | |
| SECONDARY | Postoperative Health Related Quality of Life | 30 days, 90 days, and 180 days postoperatively | T-Score | MEDIAN | |
| SECONDARY | Blood Delirium Biomarkers | perioperative | |||
| SECONDARY | EEG Delirium Biomarkers | intraoperative | |||
| OTHER_PRE_SPECIFIED | Length of Hospital Stay | from postoperative day 0 until date of hospital discharge (no prespecified length possible) | days | MEDIAN |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Delirium | Dexmedetomidine-induced Sleep | 5 | Participants | ||
| Incidence of Delirium | Placebo | 16 | Participants | ||
| ICU Delirium/Coma-free Days | Dexmedetomidine-induced Sleep | 0 Days | 0 | Participants | |
| ICU Delirium/Coma-free Days | Placebo | 0 Days | 2 | Participants | |
| ICU Delirium/Coma-free Days | Dexmedetomidine-induced Sleep | 1 Day | 6 | Participants | |
| ICU Delirium/Coma-free Days | Placebo | 1 Day | 7 | Participants | |
| ICU Delirium/Coma-free Days | Dexmedetomidine-induced Sleep | 2 Days | 8 | Participants | |
| ICU Delirium/Coma-free Days | Placebo | 2 Days | 16 | Participants | |
| ICU Delirium/Coma-free Days | Dexmedetomidine-induced Sleep | 3 Days | 146 | Participants | |
| ICU Delirium/Coma-free Days | Placebo | 3 Days | 152 | Participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexmedetomidine-induced Sleep | 234 | |
| Overall Study | STARTED | Placebo | 235 | |
| Overall Study | Analysis Population | Dexmedetomidine-induced Sleep | 188 | |
| Overall Study | Analysis Population | Placebo | 206 | |
| Overall Study | COMPLETED | Dexmedetomidine-induced Sleep | 188 | |
| Overall Study | COMPLETED | Placebo | 206 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine-induced Sleep | 46 | |
| Overall Study | NOT COMPLETED | Placebo | 29 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine-induced Sleep | 4 | 188 |
| Total, all-cause mortality | Placebo | 4 | 206 |
| Total, other adverse events | Dexmedetomidine-induced Sleep | 0 | 188 |
| Total, other adverse events | Placebo | 0 | 206 |
| Total, serious adverse events | Dexmedetomidine-induced Sleep | 0 | 188 |
| Total, serious adverse events | Placebo | 0 | 206 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG053582 | Pathophysiology of postoperative delirium and the use of biomimetic sleep as a treatment strategy in the CSICU | JOHNSON-AKEJU, OLUWASEUN | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE ON AGING | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dexmedetomidine-induced Sleep vs Placebo: Incidence of Delirium | Trial comparisons |
| Dexmedetomidine-induced Sleep vs Placebo: deaths from any cause | Trial comparisons |
| Dexmedetomidine-induced Sleep 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.
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/NCT02856594
GET https://conductscience.org/api/trials/v1/NCT02856594/results?page=2