Trial · NCT00561678
Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve
NCT00561678, Phase 4, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2017-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve. Trials, record NCT00561678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00561678
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve
- NCT number
- NCT00561678
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 404 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Postoperative Delirium, PD, Postoperative Cognitive Dysfunction, POCD
- Interventions
- Precedex (Dexmedetomidine), Placebo
- First posted
- 2007-11-21
- Last updated
- 2018-04-23
- Results first posted
- 2017-03-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Delirium Battery | Day 1 | Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU) |
| Secondary | Neuropsychological Testing | at 3 months postoperatively | Rate of change of cognitive function - data not collected because secondary analysis which was not performed |
| Secondary | Intraoperative Bradycardia | day 1 | Number of participants with intraoperative bradycardia |
| Secondary | Intraoperative Hypotension | day 1 | Number of participants with intraoperative hypotension |
| Secondary | Intraoperative Hypertension | day 1 | Number of participants with intraoperative hypertension |
| Secondary | Length of Stay | average 4 days | Length of Stay (LOS) in the hospital |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Delirium Battery | Day 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Neuropsychological Testing | at 3 months postoperatively | |||
| SECONDARY | Intraoperative Bradycardia | day 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Intraoperative Hypotension | day 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Intraoperative Hypertension | day 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Length of Stay | average 4 days | days | MEDIAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Delirium Battery | Precedex | Postoperative Delirium | 23 | Participants | |
| Delirium Battery | Placebo | Postoperative Delirium | 23 | Participants | |
| Delirium Battery | Precedex | PACU Delirium | 6 | Participants | |
| Delirium Battery | Placebo | PACU Delirium | 8 | Participants | |
| Delirium Battery | Precedex | Both | 5 | Participants | |
| Delirium Battery | Placebo | Both | 4 | Participants | |
| Delirium Battery | Precedex | None | 155 | Participants | |
| Delirium Battery | Placebo | None | 166 | Participants | |
| Intraoperative Bradycardia | Precedex | Requiring treatment | 35 | Participants | |
| Intraoperative Bradycardia | Placebo | Requiring treatment | 20 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Precedex | 197 | |
| Overall Study | STARTED | Placebo | 207 | |
| Overall Study | COMPLETED | Precedex | 189 | |
| Overall Study | COMPLETED | Placebo | 201 | |
| Overall Study | NOT COMPLETED | Precedex | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events28
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 | Events |
|---|---|---|---|---|---|---|
| serious | Myocardial Infarction | Cardiac disorders | Precedex | 1 | 189 | |
| serious | Myocardial Infarction | Cardiac disorders | Placebo | 0 | 201 | |
| serious | Unstable Angina | Cardiac disorders | Precedex | 1 | 189 | |
| serious | Unstable Angina | Cardiac disorders | Placebo | 0 | 201 | |
| serious | New Arrhythmia | Cardiac disorders | Precedex | 2 | 189 | |
| serious | New Arrhythmia | Cardiac disorders | Placebo | 4 | 201 | |
| serious | Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Precedex | 1 | 189 | |
| serious | Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 201 | |
| serious | Heart Failure | Cardiac disorders | Precedex | 1 | 189 | |
| serious | Heart Failure | Cardiac disorders | Placebo | 1 | 201 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Precedex | 1 | 189 |
| Total, all-cause mortality | Placebo | 3 | 201 |
| Total, other adverse events | Precedex | 0 | 189 |
| Total, other adverse events | Placebo | 0 | 201 |
| Total, serious adverse events | Precedex | 12 | 189 |
| Total, serious adverse events | Placebo | 9 | 201 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28593326 | RESULT |
Source PubMed
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 |
|---|---|---|---|---|---|
| R01AG029656 | Perioperative Cognitive Protection-Dexmedetomidine and Cognitive Reserve | SILVERSTEIN, JEFFREY H | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL INSTITUTE ON AGING | 2007 to 2011 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Precedex vs Placebo: deaths from any cause | Trial comparisons |
| Precedex 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/NCT00561678
GET https://conductscience.org/api/trials/v1/NCT00561678/results?page=2