DeliriumEMODIPODNCT03330236
EEG - Guided Anesthetic Care and Postoperative Delirium
A study testing Anesthetic "depth" management in people with Delirium and Emergence Delirium, run by Yale University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Delirium, Emergence Delirium, Anesthesia, General
- What is being tested?
- Anesthetic "depth" management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2017to 6 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Delirium, Emergence Delirium, Anesthesia, General, Electroencephalography, Laparoscopy, Surgical Procedures, Operative
- Being tested
- Anesthetic "depth" management
- Keywords
- Electroencephalography, Spectral edge frequency, Patient state index, Anesthesia, Laparoscopic surgery, Postoperative delirium, Emergence delirium
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic "depth" managementDevice
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 group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | 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. Receives: Device: Anesthetic "depth" management |
| Control arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to five (5) days after surgery
Secondary outcomes (7)
Emergence Delirium
Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)
Measured: 30 min following the extubation
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
Measured: within 30 days after surgery
GI Functional Recovery
Speed of GI functional recovery (pass gas)
Measured: within 30 days after surgery
All-cause 30-day Mortality
All-cause 30-day mortality
Measured: 30 days after surgery
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.
Measured: up to 30 days after surgery
ICU Admission
Count of patients that were admitted to ICU after surgery.
Measured: up to 72 hours
Length of ICU Stay
the duration of time when the patient residing in ICU
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start13 Oct 2017
- Primary completion5 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a prospective, pragmatic, patient and outcome assessor blinded, randomized 1:1 and controlled parallel trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Stavris, Study director, Yale School of Medicine Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330236
- Sponsor's protocol ID
- 201612631
- Acronym
- EMODIPOD
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2017
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03330236
- Acronym / sponsor ID
- EMODIPOD / 201612631
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,560 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 9 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a prospective, pragmatic, patient and outcome assessor blinded, randomized 1:1 and controlled parallel trial.
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: Anesthetic "depth" managementAll 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. |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthetic "depth" managementThe 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. | Device | Study arm |
Primary outcome
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.
7 secondary outcomes
Emergence Delirium
Time frame: 30 min following the extubation
Non-delirium Complications
Time frame: within 30 days after surgery
GI Functional Recovery
Time frame: within 30 days after surgery
All-cause 30-day Mortality
Time frame: 30 days after surgery
Length of Hospital Stay
Time frame: up to 30 days after surgery
ICU Admission
Time frame: up to 72 hours
Length of ICU Stay
Time frame: up to 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Stavris study director
Yale School of Medicine Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthetic "depth" management in people with Delirium and Emergence Delirium, run by Yale University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Delirium (time frame: up to five (5) days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.