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

Not Applicable

Completed

• Conditions: Sevoflurane; Electroencephalogram; Postoperative Delirium
• Interventions: Drug: Low MAC; Drug: High MAC

• Registration Number: NCT04292561
• Lead Sponsor: The First Affiliated Hospital of Anhui Medical University

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.

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 Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-02-29
• Study Start: 2020-03-01
• Study First Posted: 2020-03-03
• Status Verified: 2022-03
• Primary Completion: 2023-01-30
• Study Completion: 2023-02-10
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
light general anesthesia	Low MAC	During anesthesia maintenance, patients were received with low concentration sevoflurane to maintain a target of 0.8 MAC.
deep general anesthesia	High MAC	During anesthesia maintenance, patients were received with high concentration sevoflurane to maintain a target of 1.0 MAC.

Primary Outcome Measures

Name	Time	Method
Incidence of POD	The 7th day after the surgery	Incidence of POD after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	30-day after surgery	Incidence of adverse events after surgery
30-day mortality	30-day after surgery	30-day mortality after surgery
length of stay	From 1st day after the surgery to 2 weeks	length of stay after surgery
EEG burst inhibition	During surgery	Duration of EEG burst inhibition

Trial Locations

Locations (1)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China