Trials Sponsors Conditions Drugs Pricing

Conditions

Anesthesia, General Delirium Electroencephalography Emergence Delirium Laparoscopy Surgical Procedures, Operative

Keywords

ElectroencephalographySpectral edge frequencyPatient state indexAnesthesiaLaparoscopic surgeryPostoperative deliriumEmergence delirium

Outcome Measures

Primary Outcomes (1)

Number of Participants With Postoperative Delirium
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.
up to five (5) days after surgery

Secondary Outcomes (7)

Emergence Delirium
30 min following the extubation
Non-delirium Complications
within 30 days after surgery

Study Arms (2)

Study arm

EXPERIMENTAL

All patients in the study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic "depth" management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.

Device: Anesthetic "depth" management

Control arm

NO INTERVENTION

All patients in the control arm will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team.

Interventions

Anesthetic "depth" managementDevice

The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring.

Study arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 50 years;
ASA Physical Score I-III

Sponsors & Collaborators

Yale University
Otherlead

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410205, China

MeSH Terms

Conditions

DeliriumEmergence Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPostoperative ComplicationsPathologic Processes

Results Point of Contact

Title: Lingzhong Meng, MD
Organization: Yale University

Study Officials

Karen Stavris
Yale School of Medicine Department of Anesthesiology
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

1,560 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details: Patients, care providers (excluding the anesthesia team taking care of the patient in the operative room), and outcome assessors are blinded to the results of randomization or group assignment.
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

November 6, 2017

EEG - Guided Anesthetic Care and Postoperative Delirium

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Study arm

Control arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Other Outcomes (2)

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Study arm

Control arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Other Outcomes (2)

You may not qualify if:

Source record

Documents

Locations