EEG - Guided Anesthetic Care and Postoperative Delirium

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial

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

Intervention / Treatment
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* Device: Anesthetic depth management


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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a prospective, pragmatic, patient and outcome assessor blinded, randomized 1:1 and controlled parallel trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>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<br>* 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.<br>|
| No Intervention: Control arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence Delirium | Incidence (count) of emergence delirium at post-anesthesia care unit (PACU) | 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 | within 30 days after surgery | 
| GI Functional Recovery | Speed of GI functional recovery (pass gas) | within 30 days after surgery | 
| All-cause 30-day Mortality | All-cause 30-day mortality | 30 days after surgery | 
| Length of Hospital Stay | Length of hospital stay was counted from the day of surgery (day 0) to the day when the patient was ready for discharge. | up to 30 days after surgery | 
| ICU Admission | Count of patients that were admitted to ICU after surgery. | up to 72 hours | 
| Length of ICU Stay | the duration of time when the patient residing in ICU | up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroencephalography, Spectral edge frequency, Patient state index, Anesthesia, Laparoscopic surgery, Postoperative delirium, Emergence delirium