EEG - Guided Anesthetic Care and Postoperative Delirium (EMODIPOD)

November 5, 2020 updated by: Yale University

Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1560

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410205
        • Xiangya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to five (5) days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emergence Delirium
Time Frame: 30 min following the extubation
Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)
30 min following the extubation
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
within 30 days after surgery
GI Functional Recovery
Time Frame: within 30 days after surgery
Speed of GI functional recovery (pass gas)
within 30 days after surgery
All-cause 30-day Mortality
Time Frame: 30 days after surgery
All-cause 30-day mortality
30 days after surgery
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.
up to 30 days after surgery
ICU Admission
Time Frame: up to 72 hours
Count of patients that were admitted to ICU after surgery.
up to 72 hours
Length of ICU Stay
Time Frame: up to 30 days after surgery
the duration of time when the patient residing in ICU
up to 30 days after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 hours after surgery
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
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Karen Stavris, Yale School of Medicine Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201612631

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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