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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine134 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

134

Conditions

Delirium, Postoperative

Interventions

BIS-guidedDEVICE

underwent intraoperative monitoring of BIS anesthesia depth

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Fourth Affiliated Hospital, School of Medicine, Zhejiang University

Jinhua, Zhejiang, China

Outcomes

Primary Outcomes

Ricker sedation-agitation scale

Delirium was assessed using the Ricker sedation-agitation scale (SAS; unable to awaken = 1, very calm = 2, calm = 3, quiet cooperation = 4, agitated = 5, very agitated = 6, and dangerously agitated = 7)

Time frame: ￭evaluate immediately after recovery and tracheal intubation removal ￭every five minutes after that ￭take the highest value until the patient leave PACU

The nursing activity score (NAS)

The nursing activity score (NAS), consists of 23 nursing items in five aspects, including monitoring health care, supporting patients and their families, and managing nursing administration. Each item was assigned a score of 1.2-32.0 according to the percentage of time spent on the task during a nurse's working day. The higher the score, the greater the workload. The NAS score of each patient ranged from 0-177, and the assessment was conducted at the beginning of resuscitation in the PACU by a trained investigator according to the nursing work items on the NAS scale. According to the nursing records of patients, the nursing workload of PACU was evaluated and by the contents of NAS scale.

Time frame: ￭at the begin of the patient enter PACU ￭end with the transfer out of the PACU ￭any nursing activitise will be scored

vital signs （Mean arterial pressure, heart rate, pulse oxygen saturation ）

collected from monitors （Mean arterial pressure, heart rate, pulse oxygen saturation）

Time frame: ￭ 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).

Comparison of complications during the PACU period

including postoperative delirium, nausea, vomiting, respiratory complications (e.g., SPO2 \< 90%, arterial oxygen partial pressure \< 60 mmHg, or interventions requiring mask compression, oxygen supply, manual mandibular ventilation, and intubation), cardiovascular-related complications (e.g., blood pressure exceeding 20% of preoperative value, HR \< 120 beats /min or \< 50 beats /min, emerging arrhythmia, and ischemia), severe pain, chills/hypothermia (skin temperature \< 35 °C), and unplanned transfer to ICU.

Data from ClinicalTrials.gov

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