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

Sponsor
The First Affiliated Hospital of Anhui Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04292561
Collaborator
(none)
500
1
2
29
17.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Low MAC
  • Drug: High MAC
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Different Sevoflurane Concentrations on Intraoperative EEG and Postoperative Delirium in Elderly Patients
Actual Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: light general anesthesia

During anesthesia maintenance, patients were received with low concentration sevoflurane to maintain a target of 0.8 MAC.

Drug: Low MAC
To maintain a target of sevoflurane inhalation concentration 0.8 MAC.

Experimental: deep general anesthesia

During anesthesia maintenance, patients were received with high concentration sevoflurane to maintain a target of 1.0 MAC.

Drug: High MAC
To maintain a target of sevoflurane inhalation concentration 1.0 MAC.

Outcome Measures

Primary Outcome Measures

  1. Incidence of POD [The 1st day after the surgery]

    Incidence of POD after surgery

  2. Incidence of POD [The 2nd day after the surgery]

    Incidence of POD after surgery

  3. Incidence of POD [The 3rd day after the surgery]

    Incidence of POD after surgery

  4. Incidence of POD [The 5th day after the surgery]

    Incidence of POD after surgery

  5. Incidence of POD [The 7th day after the surgery]

    Incidence of POD after surgery

Secondary Outcome Measures

  1. EEG burst inhibition [During surgery]

    Frequency of EEG burst inhibition

  2. EEG burst inhibition [During surgery]

    Duration of EEG burst inhibition

  3. Incidence of adverse events [30-day after surgery]

    Incidence of adverse events after surgery

  4. length of stay [From 1st day after the surgery to 2 weeks]

    length of stay after surgery

  5. 30-day mortality [30-day after surgery]

    30-day mortality after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China 230022

Sponsors and Collaborators

  • The First Affiliated Hospital of Anhui Medical University

Investigators

  • Principal Investigator: Xuesheng Liu, MD.PHD, The First Affiliated Hospital of Anhui Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier:
NCT04292561
Other Study ID Numbers:
  • 201912
First Posted:
Mar 3, 2020
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022