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NCT Number: NCT04292561

Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia

Delirium is an acute onset of attentional and cognitive impairment. BIS guided anesthesia can reduce the incidence of postoperative delirium. Long term electroencephalogram (EEG) suppression during operation is related to postoperative delirium. The latest research shows that the anesthesia depth guided by EEG does not reduce the incidence of postoperative delirium. The purpose of this study was to explore the relationship between anesthesia exposure with different minimum alveolar concentration(MAC) and postoperative delirium(POD), and to observe the characteristics of EEG.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Electroencephalogram Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sevoflurane Signs and Symptoms

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

About this study

More and more studies have focused on the relationship between EEG inhibition and postoperative delirium in general anesthesia. At present, there are two kinds of commonly processed quantitative EEG monitoring to evaluate the depth of anesthesia, one is bispectral index (BIS) and the other is patient state index (PSI). The relationship between intraoperative anesthetic exposure and postoperative delirium is unclear, or whether potential patient characteristics increase the risk of EEG suppression and postoperative delirium.

Gastrointestinal surgery can lead to long-term changes in colonic flora, which can remotely regulate brain function through the gut brain axis. We speculated that the abnormal composition of intestinal flora before abdominal operation might be the influencing factor of POD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of gastrointestinal diseases
  • Patients were aged 60 to 90 years
  • American Society of Anesthesiologists (ASA) risk classification II-IV
  • Patients were scheduled to undergo elective major abdominal operation(with a anticipated time of 2-6 h)

Exclusion criteria

  • Preoperative dementia or cognitive impairment
  • Mental instability or mental illness
  • Patients with any factors affecting cognitive assessment, such as language, vision and hearing impairment
  • Any cerebrovascular accident occurred within 3 months, such as stroke etc
  • Previous history of delirium
  • Known hypersensitivity to sevoflurane or history of malignant hyperthermia
  • Abuse of narcotic sedative and analgesic drugs
  • Those who have reoperation within 7 days after operation

Treatment and study plan

Low MAC

Drug

To maintain a target of sevoflurane inhalation concentration 0.8 MAC.

High MAC

Drug

To maintain a target of sevoflurane inhalation concentration 1.0 MAC.

Primary outcomes

  1. Incidence of POD

    Time frame: The 1st day after the surgery

    Incidence of POD after surgery

  2. Incidence of POD

    Time frame: The 2nd day after the surgery

    Incidence of POD after surgery

  3. Incidence of POD

    Time frame: The 3rd day after the surgery

    Incidence of POD after surgery

  4. Incidence of POD

    Time frame: The 5th day after the surgery

    Incidence of POD after surgery

  5. Incidence of POD

    Time frame: The 7th day after the surgery

    Incidence of POD after surgery

Secondary outcomes

  1. EEG burst inhibition

    Time frame: During surgery

    Frequency of EEG burst inhibition

  2. EEG burst inhibition

    Time frame: During surgery

    Duration of EEG burst inhibition

  3. Incidence of adverse events

    Time frame: 30-day after surgery

    Incidence of adverse events after surgery

  4. length of stay

    Time frame: From 1st day after the surgery to 2 weeks

    length of stay after surgery

  5. 30-day mortality

    Time frame: 30-day after surgery

    30-day mortality after surgery

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

Effects of Different Sevoflurane Concentrations on Intraoperative EEG and Postoperative Delirium in Elderly Patients

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2020
Registry last updated
Feb 24, 2023

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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