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

NCT06302517 | Completed

• 1 other identifier: K2020097
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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)

Conditions

Delirium, Postoperative

Keywords

bispectral index; postoperative delirium

Outcome Measures

Primary Outcomes (5)

• 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)

  ￭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.

  ￭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）

  ￭ 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.

  The patients were transferred to PACU after surgery, the period during the PACU

• The comprehensive satisfaction score

  The comprehensive satisfaction score for anesthesia and nursing. The satisfaction score was categorized as excellent or generally poor based on criteria such as postoperative pain, influence on daily activities, and emotional stability. Excellent satisfaction indicated no or mild pain after surgery, no interference with daily activities, and emotional stability. General satisfaction indicated moderate pain that was tolerable, daily activities that were not affected or slightly reduced, and emotional stability. Poor satisfaction indicated moderate pain, significantly limited patient activities, low mood, or irritability.

  The patients were followed up 24 hours after surgery

Study Arms (2)

non-BIS-guided group (group C)

NO INTERVENTION

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

BIS-guided group (group B)

EXPERIMENTAL

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

Device: BIS-guided

Interventions

BIS-guided DEVICE

underwent intraoperative monitoring of BIS anesthesia depth

BIS-guided group (group B)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ranging from 20 to 80 years
• estimated operation time of 2 to 3 h
• body mass index ≤30 kg/m2
• normal preoperative heart, liver, lung, and renal function.

You may not qualify if:

• Past cognitive impairment (dementia, cognitive impairment, mental illness or mental disorder)
• Complex injuries: multiple fractures, chest and abdomen, pelvic and sacral trauma, head trauma, etc
• Contraindications to intraspinal puncture (coagulation dysfunction, thrombocytopenia, intraspinal space occupation, puncture site infection, etc.)
• Have a history of acute myocardial infarction or stroke within 3 months
• Patients with severe liver dysfunction (Child-Pugh C) or renal failure
• Contraindications to ketamine, such as malignant hypertension

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital, School of Medicine, Zhejiang University

Jinhua, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 8, 2024
• Study Start: September 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: August 29, 2022
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)