Abdominal diseases
Conditions
Interventions
Dual monitoring group (DM):At the same time, continuously monitor the BIS value (target range 40-60) and rSO2 (monitored by a near-infrared spectrometer on both frontal lobes, recording the baseline v
Single monitoring Group (SM):Continuous monitoring of the BIS value during the operation (target range: 40 - 60)
Sponsors
Chengdu Second People’s Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participate in this trial and sign the written informed consent form. 2. They are scheduled to undergo elective laparoscopic surgery (such as cholecystectomy, radical resection of colorectal cancer, radical gastrectomy, etc., with a duration of 1-4 hours). 3. They are aged 65 years or older (including the boundary value), with no gender restrictions. 4. Their American Society of Anesthesiologists (ASA) score is II to III. 5. Their Body Mass Index (BMI) is between 18.0 kg/m^2 and 30.0 kg/m². 6. Their Mini-Mental State Examination (MMSE) score is >= 24 points and their Activities of Daily Living (ADL) score is >=60 points before the operation.
Exclusion criteria
Exclusion criteria: 1.Patients with a history or current presence of mental or neurological disorders such as migraine, anxiety, epilepsy, cognitive dysfunction, etc., which the investigator believes may interfere with the study assessment; 2.Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 6 months prior to selection: acute coronary syndrome, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), congestive heart failure (NYHA class III or IV), severe or treated arrhythmia, cerebrovascular accident (including TIA); 3.Patients with a history of head trauma, intracranial surgery, or stroke within 4 weeks before surgery, or those with organic lesions of the central nervous system and consciousness disorders, as determined by the investigator to affect the evaluation of analgesic efficacy; 4. Patients who have used the following drugs within 5 half-lives before randomization: NSAIDs (including compound preparations containing NSAIDs), opioids, anesthetics, sedatives, hypnotics, anticonvulsants, antipsychotics, other central nervous system depressants, and glucocorticoids (except for topical and inhalation use); 5. Patients with any of the following specific abnormal laboratory screening values: ALT and/or AST > 2 times the upper limit of normal; BUN > 2 times the upper limit of normal, or Cr > the upper limit of normal; Hb < 90g/L; 6. Patients with head and facial skin lesions that affect the adhesion of BIS or rSO2 sensors; 7. Patients who are expected to be unable to cooperate with the completion of the recovery quality assessment after surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 24-hour, 72-hour and 7-day quality of recovery (QoR-40) scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total dosage of anesthetic drugs (propofol, sevoflurane, opioid drugs) during the operation;Postoperative extubation time;Pain scores (NRS) at rest and during activity at 24 hours and 48 hours after surgery;Sleep quality scores at 24 hours and 48 hours after the operation;The incidence of nausea and vomiting within 48 hours after the operation;The time for the first functional exercise after surgery to get out of bed;The incidence of delirium within 7 days after surgery (as measured by the CAM-C scale);The incidence of pulmonary infection one week after the operation;Cognitive function one month after the operation (as measured by the MMSE scale);Length of hospital stay; | — |
Countries
China
Contacts
Public ContactMan Yang
Chengdu Second People’s Hospital
Outcome results
None listed