Trial · NCT03330236
EEG - Guided Anesthetic Care and Postoperative Delirium
NCT03330236, Not applicable, Completed, Yale University; results first posted 2020-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EEG - Guided Anesthetic Care and Postoperative Delirium. Trials, record NCT03330236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03330236
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EEG - Guided Anesthetic Care and Postoperative Delirium
- NCT number
- NCT03330236
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,560 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Delirium, Emergence Delirium, Anesthesia, General, Electroencephalography, Laparoscopy, Surgical Procedures, Operative
- Interventions
- Anesthetic "depth" management
- First posted
- 2017-11-06
- Last updated
- 2020-11-09
- Results first posted
- 2020-11-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Postoperative Delirium | up to five (5) days after surgery | The Number of Participants with Postoperative Delirium is operationally defined as the count of patients with postoperative delirium. Postoperative delirium is an acute brain dysfunction characterized by inattention, disorganized thinking, and a fluctuating course. |
| Secondary | Emergence Delirium | 30 min following the extubation | Incidence (count) of emergence delirium at post-anesthesia care unit (PACU) |
| Secondary | Non-delirium Complications | within 30 days after surgery | Complications after surgery such as acute kidney injury, cardiac events, cerebrovascular events, renal injury, GI complications, infections (etc) were assessed using the Clavien-Dindo classification. Reported are the count of those with a composite complication Clavien-Dindo Grade ≥II. The classifications are as follows: Grade I = Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included. Grade III = Requiring surgical, endoscopic or radiological intervention; IIIa = Intervention not under general anesthesia; IIIb = Intervention under general anesthesia. Grade IV = Life-threatening complication (including CNS complications)\* requiring IC/ICU-management; IVa = single organ dysfunction (including dialysis); IVb |
| Secondary | GI Functional Recovery | within 30 days after surgery | Speed of GI functional recovery (pass gas) |
| Secondary | All-cause 30-day Mortality | 30 days after surgery | All-cause 30-day mortality |
| Secondary | Length of Hospital Stay | up to 30 days after surgery | Length of hospital stay was counted from the day of surgery (day 0) to the day when the patient was ready for discharge. |
| Secondary | ICU Admission | up to 72 hours | Count of patients that were admitted to ICU after surgery. |
| Secondary | Length of ICU Stay | up to 30 days after surgery | the duration of time when the patient residing in ICU |
| Other | NRS Pain Score | 24 hours after surgery | Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain. |
| Other | NRS Sleep Score | 24 hours after surgery | Numeric Rating Scale subjective sleep quality at 8:00 am where 0 indicates best possible sleep and 10 indicates worst possible sleep |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Postoperative Delirium | up to five (5) days after surgery | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Emergence Delirium | 30 min following the extubation | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Non-delirium Complications | within 30 days after surgery | Modified ITT population/patients with valid data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | GI Functional Recovery | within 30 days after surgery | These data were not collected and analyzed. | ||
| SECONDARY | All-cause 30-day Mortality | 30 days after surgery | Modified ITT population/patients with complete data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of Hospital Stay | up to 30 days after surgery | Modified ITT population | days | MEDIAN |
| SECONDARY | ICU Admission | up to 72 hours | Modified ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of ICU Stay | up to 30 days after surgery | These data were not collected and analyzed. | ||
| OTHER_PRE_SPECIFIED | NRS Pain Score | 24 hours after surgery | These data were not collected and analyzed. | ||
| OTHER_PRE_SPECIFIED | NRS Sleep Score | 24 hours after surgery | These data were not collected and analyzed. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Postoperative Delirium | EEG Guided | 8 | Participants | ||
| Number of Participants With Postoperative Delirium | Usual Care | 9 | Participants | ||
| Emergence Delirium | EEG Guided | 91 | Participants | ||
| Emergence Delirium | Usual Care | 102 | Participants | ||
| Non-delirium Complications | EEG Guided | 175 | Participants | ||
| Non-delirium Complications | Usual Care | 193 | Participants | ||
| All-cause 30-day Mortality | EEG Guided | 2 | Participants | ||
| All-cause 30-day Mortality | Usual Care | 1 | Participants | ||
| Length of Hospital Stay | EEG Guided | 6 | Inter-Quartile Range 3 to 8 | days | |
| Length of Hospital Stay | Usual Care | 6 | Inter-Quartile Range 3 to 8 | days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EEG Guided | 779 | |
| Overall Study | STARTED | Usual Care | 781 | |
| Overall Study | Received Surgery | EEG Guided | 779 | |
| Overall Study | Received Surgery | Usual Care | 781 | |
| Overall Study | Modified ITT | EEG Guided | 773 | |
| Overall Study | Modified ITT | Usual Care | 774 | |
| Overall Study | COMPLETED | EEG Guided | 679 | |
| Overall Study | COMPLETED | Usual Care | 697 | |
| Overall Study | NOT COMPLETED | EEG Guided | 100 | |
| Overall Study | NOT COMPLETED | Usual Care | 84 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| other | Intraoperative awareness | General disorders | EEG Guided | 3 | 779 | 3 |
| other | Intraoperative awareness | General disorders | Usual Care | 3 | 781 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EEG Guided | 2 | 779 |
| Total, all-cause mortality | Usual Care | 1 | 781 |
| Total, other adverse events | EEG Guided | 3 | 779 |
| Total, other adverse events | Usual Care | 3 | 781 |
| Total, serious adverse events | EEG Guided | 0 | 779 |
| Total, serious adverse events | Usual Care | 0 | 781 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EEG Guided vs Usual Care: All-cause 30-day Mortality | Trial comparisons |
| EEG Guided vs Usual Care: ICU Admission | Trial comparisons |
| EEG Guided vs Usual Care: Non-delirium Complications | Trial comparisons |
| EEG Guided vs Usual Care: Number of Participants With Postoperative Delirium | Trial comparisons |
| EEG Guided vs Usual Care: deaths from any cause | Trial comparisons |
| EEG Guided vs Usual Care: Emergence Delirium | Trial comparisons |
| EEG Guided vs Usual Care: 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/NCT03330236
GET https://conductscience.org/api/trials/v1/NCT03330236/registered