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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
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Delirium Emergence Delirium Anesthesia, General Electroencephalography Laparoscopy Surgical Procedures, Operative Device: Anesthetic "depth" management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1560 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Postoperative delirium [ Time Frame: up to five (5) days after surgery ]
    Incidence of postoperative delirium, an acute brain dysfunction characterized by inattention, disorganized thinking, and a fluctuating course.


Secondary Outcome Measures :
  1. Emergence delirium [ Time Frame: 30 min following the extubation ]
    Incidence of emergence delirium at post-anesthesia care unit (PACU)

  2. 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.

  3. GI functional recovery [ Time Frame: within 30 days after surgery ]
    Speed of GI functional recovery (pass gas)

  4. All-cause 30-day mortality [ Time Frame: 30 days after surgery ]
    All-cause 30-day mortality

  5. Length of hospital stay [ Time Frame: up to 30 days after surgery ]
    Length of hospital stay

  6. ICU admission [ Time Frame: up to 72 hours ]
    whether or not the patient is admitted to ICU after surgery

  7. length of ICU stay [ Time Frame: up to 30 days after surgery ]
    the duration of time when the patient residing in ICU


Other Outcome Measures:
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Hunan
Xiangya Hospital
Changsha, Hunan, China, 410205
Sponsors and Collaborators
Yale University
Investigators
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Study Director: Karen Stavris Yale School of Medicine Department of Anesthesiology
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03330236    
Other Study ID Numbers: 201612631
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Yale University:
Electroencephalography
Spectral edge frequency
Patient state index
Anesthesia
Laparoscopic surgery
Postoperative delirium
Emergence delirium
Additional relevant MeSH terms:
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Delirium
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs