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Completed

NCT Number: NCT03330236

EEG - Guided Anesthetic Care and Postoperative Delirium

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

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Key information

Conditions

Delirium Anesthesia, General Confusion Electroencephalography Emergence Delirium Laparoscopy Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Procedures, Operative

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiangya Hospital

Changsha, Hunan, 410205, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anesthetic "depth" management

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. Emergence Delirium

    Time frame: 30 min following the extubation

    Incidence (count) 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) 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

  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 was counted from the day of surgery (day 0) to the day when the patient was ready for discharge.

  6. ICU Admission

    Time frame: up to 72 hours

    Count of patients that were 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Acronym: EMODIPOD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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