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Effect of BIS-guided two distinct anesthetic depth on postoperative delirium among older adults undergoing non-cardiac major surgery: a randomized controlled study

Effect of BIS-guided two distinct anesthetic depth on postoperative delirium among older adults undergoing non-cardiac major surgery: a randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080082
Enrollment
Unknown
Registered
2024-01-19
Start date
2024-01-19
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Noncardiac Surgery

Interventions

High BIS group (light anesthesia group):BIS value 55±5
Low BIS group (deep anesthesia group):BIS value 40±5

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: ?Elective non-cardiac surgery with general anesthesia; ?Age =65 years old; ? the American Society of anesthesiologists (ASA) Grade II-IV; ?Estimated duration of operation > 2h or estimated duration of anesthesia > 3h; ?The patient agrees and signs the informed consent form.

Exclusion criteria

Exclusion criteria: ?The requirements of surgical operation or the patient's surgical position make it impossible to carry out BIS monitoring; ?planned surgery for intraoperative arousal; ?Patients with central nervous system diseases (such as having had a stroke and having sequelae); ?are using psychiatric medication; ?the presence of delirium before surgery; (6) Unable to cooperate with the study for any reason (such as visual impairment, hearing impairment, inability to communicate normally in Chinese, etc.) or the investigator believes that it is not suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
postoperative delirium;

Secondary

MeasureTime frame
Episodes of delirium;Preoperative and postoperative 48 hours inflammatory indicators;postoperation pain;mortality;Length of stay in PACU, ICU and hospital stay;medical expenditure;MMSE at discharge;Readmission rates within 30 days after surgery;postoperative cognitive function;postoperative activity of daily living;

Countries

China

Contacts

Public ContactQian Li

West China hospital, Sichuan University

hxliqian@foxmail.com+86 189 8060 1635

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026