EEG - Guided Anesthetic Care and Postoperative Delirium (EMODIPOD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03330236|
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : November 9, 2020
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Delirium Emergence Delirium Anesthesia, General Electroencephalography Laparoscopy Surgical Procedures, Operative||Device: Anesthetic "depth" management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1560 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study is a prospective, pragmatic, patient and outcome assessor blinded, randomized 1:1 and controlled parallel trial.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial|
|Actual Study Start Date :||October 13, 2017|
|Actual Primary Completion Date :||September 5, 2019|
|Actual Study Completion Date :||September 6, 2019|
Experimental: Study arm
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
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.
No Intervention: Control arm
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.
- Number of Participants With Postoperative Delirium [ Time Frame: 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.
- Emergence Delirium [ Time Frame: 30 min following the extubation ]Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)
- Non-delirium Complications [ Time Frame: 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
- GI Functional Recovery [ Time Frame: within 30 days after surgery ]Speed of GI functional recovery (pass gas)
- All-cause 30-day Mortality [ Time Frame: 30 days after surgery ]All-cause 30-day mortality
- Length of Hospital Stay [ Time Frame: 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.
- ICU Admission [ Time Frame: up to 72 hours ]Count of patients that were admitted to ICU after surgery.
- Length of ICU Stay [ Time Frame: up to 30 days after surgery ]the duration of time when the patient residing in ICU
- NRS Pain Score [ Time Frame: 24 hours after surgery ]Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain.
- NRS Sleep Score [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330236
|Changsha, Hunan, China, 410205|
|Study Director:||Karen Stavris||Yale School of Medicine Department of Anesthesiology|