Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia

NCT ID: NCT06302517

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-08-29

Brief Summary

①Effects of BIS Index (BIS) monitoring on delirium incidence in Post-anesthesia care unit (PACU) in patients undergoing general anesthesia

②Effects of BIS BIS Index (BIS) monitoring on the quality of nursing care in the Post-anesthesia care unit (PACU)

Detailed Description

The effect of intraoperative anesthesia depth monitoring on delirium occurrence and improvement of nursing quality in the post-anesthesia care unit (PACU) remains unclear. We aimed to explore the effect of intraoperative anesthesia bispectral index (BIS) monitoring on delirium occurrence and improvement of nursing quality in the PACU for patients recovering from general anesthesia.

This randomized controlled trial included 120 patients, aged 20-80 years and classified as grades I-III according to the American Society of Anesthesiologists. The BIS-guided group (group B) underwent intraoperative monitoring of BIS anesthesia depth (maintained within the anesthetic range [40-60]). The depth of anesthesia was not monitored in the non-BIS-guided group (group C). The patients' vital signs were recorded at the beginning of the operation (T0), upon entering the PACU (T1), 15 min after extubation (T2), and after leaving the PACU (T3). Delirium score, emergence period (extubation and PACU observation times), and adverse events in the PACU were monitored. The nursing activity score (NAS) was used to evaluate the quality of care.

Conditions

Delirium, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

non-BIS-guided group (group C)

The depth of anesthesia was not monitored in the non-BIS-guided group (group C).

Group Type: NO_INTERVENTION

No interventions assigned to this group

BIS-guided group (group B)

The BIS-guided group (group B) underwent intraoperative monitoring of BIS anesthesia depth

Group Type: EXPERIMENTAL

BIS-guided

Intervention Type: DEVICE

underwent intraoperative monitoring of BIS anesthesia depth

Interventions

BIS-guided

underwent intraoperative monitoring of BIS anesthesia depth

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. age ranging from 20 to 80 years

2. estimated operation time of 2 to 3 h

3. body mass index ≤30 kg/m2

4. normal preoperative heart, liver, lung, and renal function.

Exclusion Criteria

1. Past cognitive impairment (dementia, cognitive impairment, mental illness or mental disorder)

2. Complex injuries: multiple fractures, chest and abdomen, pelvic and sacral trauma, head trauma, etc

3. Contraindications to intraspinal puncture (coagulation dysfunction, thrombocytopenia, intraspinal space occupation, puncture site infection, etc.)

4. Have a history of acute myocardial infarction or stroke within 3 months

5. Patients with severe liver dysfunction (Child-Pugh C) or renal failure

6. Contraindications to ketamine, such as malignant hypertension

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fourth Affiliated Hospital, School of Medicine, Zhejiang University

Jinhua, Zhejiang, China

Countries

China

Other Identifiers

K2020097

Identifier Type: -

Identifier Source: org_study_id