Back to resultsIntraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia
Primary Purpose
Postoperative Delirium, Sevoflurane, Electroencephalogram
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low MAC
High MAC
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Delirium
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
Sites / Locations
- The First Affiliated Hospital of Anhui Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
light general anesthesia
deep general anesthesia
Arm Description
During anesthesia maintenance, patients were received with low concentration sevoflurane to maintain a target of 0.8 MAC.
During anesthesia maintenance, patients were received with high concentration sevoflurane to maintain a target of 1.0 MAC.
Outcomes
Primary Outcome Measures
Incidence of POD
Incidence of POD after surgery
Incidence of POD
Incidence of POD after surgery
Incidence of POD
Incidence of POD after surgery
Incidence of POD
Incidence of POD after surgery
Incidence of POD
Incidence of POD after surgery
Secondary Outcome Measures
EEG burst inhibition
Frequency of EEG burst inhibition
EEG burst inhibition
Duration of EEG burst inhibition
Incidence of adverse events
Incidence of adverse events after surgery
length of stay
length of stay after surgery
30-day mortality
30-day mortality after surgery
Full Information
NCT ID
NCT04292561
First Posted
January 8, 2020
Last Updated
February 23, 2023
Sponsor
The First Affiliated Hospital of Anhui Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04292561
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Anhui Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, Sevoflurane, Electroencephalogram
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
light general anesthesia
Arm Type
Experimental
Arm Description
During anesthesia maintenance, patients were received with low concentration sevoflurane to maintain a target of 0.8 MAC.
Arm Title
deep general anesthesia
Arm Type
Experimental
Arm Description
During anesthesia maintenance, patients were received with high concentration sevoflurane to maintain a target of 1.0 MAC.
Intervention Type
Drug
Intervention Name(s)
Low MAC
Intervention Description
To maintain a target of sevoflurane inhalation concentration 0.8 MAC.
Intervention Type
Drug
Intervention Name(s)
High MAC
Intervention Description
To maintain a target of sevoflurane inhalation concentration 1.0 MAC.
Primary Outcome Measure Information:
Title
Incidence of POD
Description
Incidence of POD after surgery
Time Frame
The 1st day after the surgery
Title
Incidence of POD
Description
Incidence of POD after surgery
Time Frame
The 2nd day after the surgery
Title
Incidence of POD
Description
Incidence of POD after surgery
Time Frame
The 3rd day after the surgery
Title
Incidence of POD
Description
Incidence of POD after surgery
Time Frame
The 5th day after the surgery
Title
Incidence of POD
Description
Incidence of POD after surgery
Time Frame
The 7th day after the surgery
Secondary Outcome Measure Information:
Title
EEG burst inhibition
Description
Frequency of EEG burst inhibition
Time Frame
During surgery
Title
EEG burst inhibition
Description
Duration of EEG burst inhibition
Time Frame
During surgery
Title
Incidence of adverse events
Description
Incidence of adverse events after surgery
Time Frame
30-day after surgery
Title
length of stay
Description
length of stay after surgery
Time Frame
From 1st day after the surgery to 2 weeks
Title
30-day mortality
Description
30-day mortality after surgery
Time Frame
30-day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuesheng Liu, MD.PHD
Organizational Affiliation
The First Affiliated Hospital of Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22311257
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.
Results Reference
background
PubMed Identifier
23027226
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.
Results Reference
background
PubMed Identifier
26418126
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.
Results Reference
background
PubMed Identifier
30721296
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.
Results Reference
background
PubMed Identifier
25860600
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.
Results Reference
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Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia
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