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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292561
• Other study ID #: 201912
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2022
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: February 10, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Electroencephalogram
• Postoperative Delirium
• Sevoflurane

Intervention

Drug:
• Low MAC
To maintain a target of sevoflurane inhalation concentration 0.8 MAC.
• High MAC
To maintain a target of sevoflurane inhalation concentration 1.0 MAC.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of POD	Incidence of POD after surgery	The 1st day after the surgery
Primary	Incidence of POD	Incidence of POD after surgery	The 2nd day after the surgery
Primary	Incidence of POD	Incidence of POD after surgery	The 3rd day after the surgery
Primary	Incidence of POD	Incidence of POD after surgery	The 5th day after the surgery
Primary	Incidence of POD	Incidence of POD after surgery	The 7th day after the surgery
Secondary	EEG burst inhibition	Frequency of EEG burst inhibition	During surgery
Secondary	EEG burst inhibition	Duration of EEG burst inhibition	During surgery
Secondary	Incidence of adverse events	Incidence of adverse events after surgery	30-day after surgery
Secondary	length of stay	length of stay after surgery	From 1st day after the surgery to 2 weeks
Secondary	30-day mortality	30-day mortality after surgery	30-day after surgery