Manual vs Automated Anesthesia : Impact On The Incidence Of POCD
NCT03148730, Not applicable, Completed, Erasme University Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Manual vs Automated Anesthesia : Impact On The Incidence Of POCD | ClinicalTrials.gov |
| NCT number | NCT03148730 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Erasme University Hospital | ClinicalTrials.gov |
| Conditions | Postoperative Delirium | ClinicalTrials.gov |
| Interventions | closed-loop group | ClinicalTrials.gov |
| First posted | 2017-05-11 | ClinicalTrials.gov |
| Last updated | 2020-01-28 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of postoperative cognitive dysfunction (POCD) | first month | assessment of the POCD using the MOCA test ( done by a psychiatrist and a psychologist). This will be done preoperatively, at postoperative day 3-5 for moderate risk surgery and postoperative day 7-10 for high risk surgery | ClinicalTrials.gov |
| Secondary | Assesment of the incidence of POCD using different others tests: | Before Surgery | 1\) assessment of verbal episodic memory (van der linden et al, 2004: RL/RI-16 2) Digit Span (assessment of short term memory: in order and reverse order (assessment of working memory) 3) Stroop test: assessment of inhibition (Chatelois, 1993). This will be done day the before surgery | ClinicalTrials.gov |
| Secondary | Assesment of the incidence of POCD using different others tests: | day 5 after surgery | 1\) assessment of verbal episodic memory (van der linden et al, 2004: RL/RI-16 2) Digit Span (assessment of short term memory: in order and reverse order (assessment of working memory) 3) Stroop test: assessment of inhibition (Chatelois, 1993). This will be done on postoperative day 3-5 (for moderate risk surgery) | ClinicalTrials.gov |
| Secondary | Assesment of the incidence of POCD using different others tests: | day 10 after surgery | 1\) assessment of verbal episodic memory (van der linden et al, 2004: RL/RI-16 2) Digit Span (assessment of short term memory: in order and reverse order (assessment of working memory) 3) Stroop test: assessment of inhibition (Chatelois, 1993). This will be done on postoperative day 7-10 for high risk surgery | ClinicalTrials.gov |
| Secondary | Long term incidence of POCD | month 3 post surgery | results of the MOCA test | ClinicalTrials.gov |
| Secondary | Assessment of the Quality of life EQ-5D-5L | 3 months | self assessment by the patient: done the day before surgery and at month 3 post surgery | ClinicalTrials.gov |
| Secondary | Assessment of Quality of recovery (QoR) | first month | self assessment by the patient: QoR-15 items: questionnaire done before surgery to provide baseline data and then repeated after surgery (post operative day 3 for moderate risk surgery and postoperative day 7for high risk surgery). | ClinicalTrials.gov |
| Secondary | Amount of i.v drugs used ( propofol, remifentanil, vasopressors) | first 24 hours | amount of iv drugs used during the surgery | ClinicalTrials.gov |
| Secondary | Amount of total fluid infused to the patient | first 24 hours | comparison of the amount of fluid administered to the patients between groups | ClinicalTrials.gov |
| Secondary | Mean BIS values and Burst suppression ratio (BSR) incidence defined as a period of isoelectric cortical signal with a treshold at 10% for > 1 minutes. | first 24 hours | comparison of the mean BIS values and occurrence of BSR between groups | ClinicalTrials.gov |
| Secondary | mean arterial pressure (MAP) during surgery | first 24 hours | comparison of the mean values of these variables between both groups | ClinicalTrials.gov |
| Secondary | Mean : mean stroke volume, stroke volume variation and cardiac output and cardiac index | first 24 hours | comparison of the mean values of these variables between both groups | ClinicalTrials.gov |
| Secondary | Incidence of postoperative complications (major and minor) | From date of surgery until day 30 after surgery | comparison of the incidence of postoperative complications between both groups | ClinicalTrials.gov |
| Secondary | Length of stay in the intensive care unit (ICU) and/or postanesthesia care unit (PACU) | From date of surgery until the date of Postanesthesia or intensive care setting discharge or date of death from any cause assessed up to 100 weeks after surgery | comparison of the length of stay between both groups | ClinicalTrials.gov |
| Secondary | Length of stay in the hospital ( | From date of surgery until the date of hopital discharge or date of death from any cause assessed up to 100 weeks after surgery | comparison of the hospital length of stay between both groups | ClinicalTrials.gov |
| Secondary | Mortality at day 30 | 30 days | death at 1 month | ClinicalTrials.gov |
| Secondary | Mortality at month 3 | 3 months | death at 3 months | ClinicalTrials.gov |
| Secondary | Comparison of performance of the automated system vs the manual group | first 24 hours | defined as the time of the surgery spent with a BIS values \[40-60\] and a SVV \<13% and/or a CI \> 2.5 l/min/m2 for | ClinicalTrials.gov |
| Secondary | Occurrence of arterial hypotension (mean arterial pressure (MAP) < 65 mmHg) | first 24 hours | MAP \< 65 mmHg | ClinicalTrials.gov |
| Secondary | Occurrence of awarness | first 24 hours | questionnaire | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)