EEG - Guided Anesthetic Care and Postoperative Delirium

Not Applicable

Completed

• Conditions: Anesthesia, General; Laparoscopy; Delirium; Electroencephalography; Surgical Procedures, Operative; Emergence Delirium
• Interventions: Device: Anesthetic "depth" management

• Registration Number: NCT03330236
• Lead Sponsor: Yale University

Brief Summary

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

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 Timeline

• Study Start: 2017-10-13
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Primary Completion: 2019-09-05
• Study Completion: 2019-09-06
• Results First Submitted: 2020-10-09
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-05
• Results First Posted: 2020-11-09
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1560

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm	Anesthetic "depth" management	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Emergence Delirium	30 min following the extubation	Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)
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
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.
GI Functional Recovery	within 30 days after surgery	Speed of GI functional recovery (pass gas)
ICU Admission	up to 72 hours	Count of patients that were admitted to ICU after surgery.
All-cause 30-day Mortality	30 days after surgery	All-cause 30-day mortality
Length of ICU Stay	up to 30 days after surgery	the duration of time when the patient residing in ICU

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, Hunan, China