Clinical trial NCT04292561: Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia
Official title: Effects of Different Sevoflurane Concentrations on Intraoperative EEG and Postoperative Delirium in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Sevoflurane
Electroencephalogram
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 460
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of POD
timeFrame: The 1st day after the surgery
measure: Incidence of POD
timeFrame: The 2nd day after the surgery
measure: Incidence of POD
timeFrame: The 3rd day after the surgery
measure: Incidence of POD
timeFrame: The 5th day after the surgery
measure: Incidence of POD
timeFrame: The 7th day after the surgery
Secondary outcomes:
measure: EEG burst inhibition
timeFrame: During surgery
measure: EEG burst inhibition
timeFrame: During surgery
measure: Incidence of adverse events
timeFrame: 30-day after surgery
measure: length of stay
timeFrame: From 1st day after the surgery to 2 weeks
measure: 30-day mortality
timeFrame: 30-day after surgery
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Xuesheng Liu, MD.PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.