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EEG - Guided Anesthetic Care and Postoperative Delirium (EMODIPOD)

Primary Purpose

Delirium, Emergence Delirium, Anesthesia, General

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anesthetic "depth" management
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Electroencephalography, Spectral edge frequency, Patient state index, Anesthesia, Laparoscopic surgery, Postoperative delirium, Emergence delirium

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study arm

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2017
Last Updated
November 5, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03330236
Brief Title
EEG - Guided Anesthetic Care and Postoperative Delirium
Acronym
EMODIPOD
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Emergence Delirium, Anesthesia, General, Electroencephalography, Laparoscopy, Surgical Procedures, Operative
Keywords
Electroencephalography, Spectral edge frequency, Patient state index, Anesthesia, Laparoscopic surgery, Postoperative delirium, Emergence delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a prospective, pragmatic, patient and outcome assessor blinded, randomized 1:1 and controlled parallel trial.
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
1560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Anesthetic "depth" management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Delirium
Description
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.
Time Frame
up to five (5) days after surgery
Secondary Outcome Measure Information:
Title
Emergence Delirium
Description
Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)
Time Frame
30 min following the extubation
Title
Non-delirium Complications
Description
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
Time Frame
within 30 days after surgery
Title
GI Functional Recovery
Description
Speed of GI functional recovery (pass gas)
Time Frame
within 30 days after surgery
Title
All-cause 30-day Mortality
Description
All-cause 30-day mortality
Time Frame
30 days after surgery
Title
Length of Hospital Stay
Description
Length of hospital stay was counted from the day of surgery (day 0) to the day when the patient was ready for discharge.
Time Frame
up to 30 days after surgery
Title
ICU Admission
Description
Count of patients that were admitted to ICU after surgery.
Time Frame
up to 72 hours
Title
Length of ICU Stay
Description
the duration of time when the patient residing in ICU
Time Frame
up to 30 days after surgery
Other Pre-specified Outcome Measures:
Title
NRS Pain Score
Description
Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain.
Time Frame
24 hours after surgery
Title
NRS Sleep Score
Description
Numeric Rating Scale subjective sleep quality at 8:00 am where 0 indicates best possible sleep and 10 indicates worst possible sleep
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Stavris
Organizational Affiliation
Yale School of Medicine Department of Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410205
Country
China

12. IPD Sharing Statement

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