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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
Results First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE October 19, 2017
First Posted Date  ICMJE November 6, 2017
Results First Submitted Date  ICMJE October 9, 2020
Results First Posted Date  ICMJE November 9, 2020
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE October 13, 2017
Actual Primary Completion Date September 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Incidence of postoperative delirium [ Time Frame: up to five (5) days ]
Delirium is an acute brain dysfunction characterized by inattention, disorganized thinking, and a fluctuating course
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • Incidence of PACU delirium [ Time Frame: 5 days ]
    Incidence of post-anesthesia care unit (PACU)
  • Incidence of non-delirium complications [ Time Frame: within 30 days ]
    Complications after surgery such as acute kidney injury, cardiac events, cerebrovascular events, renal injury, GI complications, infections etc.
  • GI function recovery [ Time Frame: within 30 days ]
    Speed of GI function recovery (pass gas)
  • All-cause 30-day Mortality [ Time Frame: 30 days ]
    All-cause 30-day mortality
  • Length of Hospital Stay [ Time Frame: up to 30 days ]
    Length of hospital stay
  • ICU Admission [ Time Frame: up to 72 hours ]
    length of time in ICU admission
  • ICU stay duration [ Time Frame: up to 7 days ]
    length of time in ICU stay
Current Other Pre-specified Outcome Measures
 (submitted: February 13, 2019)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: October 30, 2017)
  • 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 postoperative day 1 ]
    Numeric Rating Scale subjective sleep quality at 8:00 am where 0 indicates best possible sleep and 10 indicates worst possible sleep
 
Descriptive Information
Brief Title  ICMJE EEG - Guided Anesthetic Care and Postoperative Delirium
Official Title  ICMJE Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Delirium
  • Emergence Delirium
  • Anesthesia, General
  • Electroencephalography
  • Laparoscopy
  • Surgical Procedures, Operative
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Anesthetic "depth" management
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
1560
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 6, 2019
Actual Primary Completion Date September 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330236
Other Study ID Numbers  ICMJE 201612631
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karen Stavris Yale School of Medicine Department of Anesthesiology
PRS Account Yale University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP