EEG - Guided Anesthetic Care and Postoperative Delirium

Yale University1,560 enrolled

Overview

The study is a prospective, double blinded, randomized and controlled parallel trial to investigate the effect of the anesthetic care guided by EEG monitor (SedLine) on postoperative delirium. EMODIPOD = Electroencephalography Monitoring tO Decrease the Incidence of PostOperative Delirium

To investigate the impact of the anesthetic care guided by EEG monitor (SedLine) on (1) the incidence of delirium in post-anesthesia care unit (PACU) and within the first five days after laparoscopic surgery and (2) the incidence of in-hospital complications and 30-day mortality in adult patients after laparoscopic surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,560

Conditions

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

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 50 years; 2. ASA Physical Score I-III 3. Scheduled to undergo elective laparoscopic surgeries under general anesthesia with endotracheal intubation; 4. Extubation expected after surgery; 5. Scheduled to stay in hospital for \> 3 days after surgery. Exclusion Criteria: 1. Refuse to participate; 2. Emergent surgery; 3. Trauma patients; 4. Preoperative cognitive impairment characterized by Mini-Mental State Examination (MMSE) of 23 or less; 5. Preoperative history of stroke, schizophrenia, major depression, Parkinson's disease, epilepsy, or dementia; 6. Inability to communicate in the preoperative period due to illiteracy, language difficulties, or significant hearing or visual impairment; 7. Inability to complete MMSE and delirium survey; 8. Severe cardiac disease including low-output cardiac failure defined as a preoperative left ventricular ejection fraction \< 30%, or arrhythmia with pacemaker or AICD placement; 9. Severe hepatic dysfunction being evaluated for liver transplantation or with a Child- Pugh Class C classification; 10. Severe renal dysfunction requiring renal replacement therapy before surgery; 11. Those with preoperative ASA classification of 4 or who are unlikely to survive for more than 3 days after surgery.

Locations (1)

Xiangya Hospital

Changsha, Hunan, China

Outcomes

Primary Outcomes

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.

Time frame: up to five (5) days after surgery

Secondary Outcomes

Emergence Delirium

Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)

Time frame: 30 min following the extubation

Non-delirium Complications

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

Time frame: within 30 days after surgery

GI Functional Recovery

Speed of GI functional recovery (pass gas)

Time frame: within 30 days after surgery

All-cause 30-day Mortality

All-cause 30-day mortality

Data from ClinicalTrials.gov

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