Clinical trial NCT06302517: Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia
Official title: Bispectral Index Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement in Post-anesthesia Care Unit Patients Recovering From General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium, Postoperative
Keywords: bispectral index; postoperative delirium
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 134
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Ricker sedation-agitation scale
timeFrame: ￭evaluate immediately after recovery and tracheal intubation removal ￭every five minutes after that ￭take the highest value until the patient leave PACU
measure: The nursing activity score (NAS)
timeFrame: ￭at the begin of the patient enter PACU ￭end with the transfer out of the PACU ￭any nursing activitise will be scored
measure: vital signs （Mean arterial pressure, heart rate, pulse oxygen saturation ）
timeFrame: ￭ at the beginning of surgery (T0), ￭at the time of extubation (T1), ￭10 minutes after extubation (T2), ￭at the time of leaving the PACU (T3: when patients were transferred from the PACU to the ward).
measure: Comparison of complications during the PACU period
timeFrame: The patients were transferred to PACU after surgery, the period during the PACU
measure: The comprehensive satisfaction score
timeFrame: The patients were followed up 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jinhua
country: China
facility: The Fourth Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: