Trial · NCT02428062
Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly
NCT02428062, Phase 2, Phase 3, Suspended, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly. Trials, record NCT02428062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02428062
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly
- NCT number
- NCT02428062
- Status
- Suspended
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,812 participants, estimated
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Conditions
- Post-operative Cognitive Dysfunction
- Interventions
- Hemodynamic target, Phenylephrine, Intravenous fluids, Patient's positioning, Reduction of depth of anesthesia, Ephedrine, Epinephrine, Norepinephrine, Dopamine
- First posted
- 2015-04-28
- Last updated
- 2018-04-13
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-operative cognitive dysfunction (POCD) at 3 months | 3 months after surgical operation | For each of the neuropsychological tests a Z-score will be calculated. The Z score represents the magnitude of the deviation (in number of standard deviations) in the test results from the reference (Control Group). The Z-score is calculated as the difference between the baseline and the 3 months test result for a patient, corrected for the expected difference (the mean difference for that test observed in the Control Group), divided by the standard deviation of the mean difference for that test observed in the Control Group. From the Z-scores of the single tests a combined Z-score can be calculated. Patients in whom the difference (worsening) in the score at 3 months to the score at baseline in at least 2 tests will be greater than 2 standard deviations from the expected difference (i.e. Z-score ≥ 2 in at least 2 tests), will be diagnosed with POCD. Also patients in which the combined Z-score will be equal or greater than 2 will be diagnosed with POCD. |
| Secondary | Post-operative cognitive dysfunction (POCD) at 1 year | 1 year after surgical operation | For each of the neuropsychological tests a Z-score will be calculated. The Z score represents the magnitude of the deviation (in number of standard deviations) in the test results from the reference (Control Group). The Z-score is calculated as the difference between the baseline and the 1 year test result for a patient, corrected for the expected difference (the mean difference for that test observed in the Control Group), divided by the standard deviation of the mean difference for that test observed in the Control Group. From the Z-scores of the single tests a combined Z-score can be calculated. Patients in whom the difference (worsening) in the score at 1 year to the score at baseline in at least 2 tests will be greater than 2 standard deviations from the expected difference (i.e. Z-score ≥ 2 in at least 2 tests), will be diagnosed with POCD. Also patients in which the combined Z-score will be equal or greater than 2 will be diagnosed with POCD. |
| Secondary | Post-operative delirium | Within 7 days after surgical operation | During the first postoperative week all patients will be evaluated on a daily basis for delirium occurrence by the CAM-ICU scale (Confusion Assessment Method for the ICU). The CAM-ICU scale defines delirium by the simultaneous occurrence of items 1, 2 and one between items 3 and 4. Items are listed below: 1. Acute alteration of mental status or fluctuating mental status in the preceding 24 hours 2. Inattention 3. Altered level of consciousness (Richmond Agitation and Sedation Scale, RASS ≠ 0) 4. Disorganized thinking |
| Secondary | Hearing loss at 3 months | 3 months after surgical operation | Clinical evaluation of worsening in hearing function |
| Secondary | Hospital length of stay | Up to 30 days after surgical operation | Number of days of hospitalization after the surgical operation |
| Secondary | Mortality | 90 days | |
| Secondary | Number of patients with at least one post-operative complication | Within 7 days after surgical operation | During the first postoperative week patients will be assessed on a daily basis for the occurrence of cardio-pulmonary (acute myocardial infarction, congestive heart failure, pulmonary embolism, cardiac arrest, atrial fibrillation, pneumonia), neurologic (ischemic or hemorrhagic stroke), renal or hemorrhagic complications. |
| Secondary | Hearing loss at 1 year | 1 year after surgical operation | Clinical evaluation of worsening in hearing function |
| Secondary | Vestibular dysfunction at 3 months | 3 months after surgical operation | Clinical evaluation of worsening of vestibular function |
| Secondary | Vestibular dysfunction at 1 year | 1 year after surgical operation | Clinical evaluation of worsening of vestibular function |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers38
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02428062
GET https://conductscience.org/api/trials/v1/NCT02428062/papers?page=2