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

NCT04292561 | Completed DMC

• 1 other identifier: 201912
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Sevoflurane; Electroencephalogram

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• EEG burst inhibition

  During surgery

• EEG burst inhibition

  During surgery

• Incidence of adverse events

  30-day after surgery

• length of stay

  From 1st day after the surgery to 2 weeks

• 30-day mortality

  30-day after surgery

Study Arms (2)

light general anesthesia

EXPERIMENTAL

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

Drug: Low MAC

deep general anesthesia

EXPERIMENTAL

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

Drug: High MAC

Interventions

Low MAC DRUG

To maintain a target of sevoflurane inhalation concentration 0.8 MAC.

light general anesthesia

High MAC DRUG

To maintain a target of sevoflurane inhalation concentration 1.0 MAC.

deep general anesthesia

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Related Publications (5)

• 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.

  PMID: 22311257 BACKGROUND

• 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.

  PMID: 23027226 BACKGROUND

• 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.

  PMID: 26418126 BACKGROUND

• 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.

  PMID: 30721296 BACKGROUND

• 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.

  PMID: 25860600 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xuesheng Liu, MD.PHD

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: March 3, 2020
• Study Start: March 1, 2020
• Primary Completion: January 30, 2023
• Study Completion: February 10, 2023
• Last Updated: February 24, 2023

Record last verified: 2022-03

Locations

CN (1)