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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-02-10

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Delirium Sevoflurane Electroencephalogram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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light general anesthesia

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

Group Type EXPERIMENTAL

Low MAC

Intervention Type DRUG

To maintain a target of sevoflurane inhalation concentration 0.8 MAC.

deep general anesthesia

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

Group Type EXPERIMENTAL

High MAC

Intervention Type DRUG

To maintain a target of sevoflurane inhalation concentration 1.0 MAC.

Interventions

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Low MAC

To maintain a target of sevoflurane inhalation concentration 0.8 MAC.

Intervention Type DRUG

High MAC

To maintain a target of sevoflurane inhalation concentration 1.0 MAC.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No