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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04292561
Enrollment
460
Registered
2020-03-03
Start date
2020-03-01
Completion date
2023-02-10
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electroencephalogram, Postoperative Delirium, Sevoflurane

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.

Interventions

DRUGLow MAC

To maintain a target of sevoflurane inhalation concentration 0.8 MAC.

DRUGHigh MAC

To maintain a target of sevoflurane inhalation concentration 1.0 MAC.

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of PODThe 1st day after the surgeryIncidence of POD after surgery

Secondary

MeasureTime frameDescription
EEG burst inhibitionDuring surgeryFrequency of EEG burst inhibition
Incidence of adverse events30-day after surgeryIncidence of adverse events after surgery
length of stayFrom 1st day after the surgery to 2 weekslength of stay after surgery
30-day mortality30-day after surgery30-day mortality after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026