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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Sevoflurane; Electroencephalogram
• Intervention / Treatment: Drug: Low MAC; Drug: High MAC

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 Type: Interventional
• Enrollment (Actual): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuesheng Liu, MD.PHD; Phone Number: 0551-62922344; Email: liu711029@hotmail.com
• Study Contact Backup: Name: Xinqi Cheng, MD.PHD; Phone Number: 0551-62922344; Email: ch_xq1983@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of POD	Incidence of POD after surgery	The 1st day after the surgery
Incidence of POD	Incidence of POD after surgery	The 2nd day after the surgery
Incidence of POD	Incidence of POD after surgery	The 3rd day after the surgery
Incidence of POD	Incidence of POD after surgery	The 5th day after the surgery
Incidence of POD	Incidence of POD after surgery	The 7th day after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG burst inhibition	Frequency of EEG burst inhibition	During surgery
EEG burst inhibition	Duration of EEG burst inhibition	During surgery
Incidence of adverse events	Incidence of adverse events after surgery	30-day after surgery
length of stay	length of stay after surgery	From 1st day after the surgery to 2 weeks
30-day mortality	30-day mortality after surgery	30-day after surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University

Publications and helpful links

General Publications

• Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
• Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
• Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
• Chaput AJ, Bryson GL. Postoperative delirium: risk factors and management: continuing professional development. Can J Anaesth. 2012 Mar;59(3):304-20. doi: 10.1007/s12630-011-9658-4. Epub 2012 Feb 4. English, French.
• Ridaura V, Belkaid Y. Gut microbiota: the link to your second brain. Cell. 2015 Apr 9;161(2):193-4. doi: 10.1016/j.cell.2015.03.033.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: February 29, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 201912

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No