Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06302517
Other study ID # K2020097
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date August 29, 2022

Study information

Verified date March 2024
Source The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date August 29, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BIS-guided
underwent intraoperative monitoring of BIS anesthesia depth

Locations

Country Name City State
China The Fourth Affiliated Hospital, School of Medicine, Zhejiang University Jinhua Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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).
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06392308 - The Impact of Smoking on the Prognosis of Elderly Surgical Patients
Recruiting NCT06090955 - Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly N/A
Recruiting NCT06052397 - Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium
Not yet recruiting NCT06107517 - DREAMS-OT Trial: Delirium Reduction Through Early Activation in Motivating and Sleep Promoting Routines: A Randomized Controlled Trial of Occupational Therapy for ICU Patients After Coronary Artery Bypass Graft (CABG) Surgery N/A
Completed NCT04563858 - Polish Validation 4AT Tool
Completed NCT06268119 - Effectiveness of Delirium Care Protocol After Cardiac Surgery N/A
Not yet recruiting NCT06268080 - Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery N/A
Recruiting NCT06360549 - Effect of Percutaneous Acupoint Electrical Stimulation on Delirium N/A
Completed NCT06187389 - Validation and Reliability of the Turkish 4AT Scale for Post-Anesthesia Awakening Delirium
Recruiting NCT01283412 - Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients Phase 3
Recruiting NCT06318364 - Postoperative Delirium in the Post-anesthesia Care Unit
Recruiting NCT06318351 - Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium
Completed NCT01032161 - Perioperative Risk Factors for Postoperative Delirium in Children N/A
Completed NCT05942183 - Optic Nerve Sheath Diameter is Associated With Postoperative Delirium in Patients Undergoing Open Heart Surgery
Not yet recruiting NCT06361238 - Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery Phase 3
Not yet recruiting NCT06346990 - The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG N/A