Sleep disorders in patients with pituitary tumors
Conditions
Interventions
Trial Group:Anesthesia induction: Remimazolam besylate 0.2-0.3 mg/kg, Sufentanil 0.3-0.5 µg/kg, Rocuronium 0.6-0.9 mg/kg
Anesthesia maintenance: Continuous infusion of remimazolam 0.1-0.3 mg/h
Control Group:Anesthesia induction: Propofol 1.5-2.5 mg/kg, Sufentanil 0.3-0.5 µg/kg, Rocuronium 0.6-0.9 mg/kg
Anesthesia maintenance: Continuous infusion of propofol 3-5 mg/kg/h
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 65 years old, gender not restricted; 2. American Society of Anesthesiologists (ASA) classification: I - III; 3. The patient intends to undergo elective transsphenoidal pituitary tumor resection under general anesthesia; 4. The preoperative Pittsburgh Sleep Quality Index (PSQI) score is >= 5 (indicating a certain degree of sleep disturbance, for observing the improvement effect); 5. The research participants or their legal representatives fully understand the research content and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There is a history of severe mental and neurological disorders (such as schizophrenia, epilepsy, Parkinson's disease, moderate to severe cognitive impairment) before the surgery; 2. Has been taking sedative-hypnotic drugs, antidepressants regularly for nearly 3 months, or has a history of drug abuse/alcoholism; 3. Has severe heart, liver, or kidney dysfunction (NYHA III-IV grade, dialysis patients, etc.); 4. Known to be allergic to benzodiazepines, remimazolam, propofol or its excipients (such as soybean oil, egg yolk lecithin); 5. Body Mass Index (BMI) > 30 kg/m^2 or has severe obstructive sleep apnea syndrome (OSA); 6. There is a difficult airway assessed before the surgery and it is not suitable for blind induction; 7. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Efficiency (SE) on Postoperative Day 1;Safety Outcomes including Intraoperative Neuropsychiatric Adverse Events and Hemodynamic Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep Architecture Parameters including Total Sleep Time (TST), Awakenings Time (ATA), Slow-Wave Sleep (SWS) Proportion, and REM Sleep Proportion;Subjective Sleep Quality assessed by Pittsburgh Sleep Quality Index (PSQI) and Athens Insomnia Scale (AIS);Biomarkers including Serum Melatonin and Orexin-A Levels;Other Clinical Outcomes including Postoperative Pain Score (NRS), Opioid Consumption, Quality of Recovery (QoR-15), Cognitive Function (MMSE), and Incidence of Postoperative Delirium (POD); | — |
Countries
China
Contacts
Public ContactWang Yingwei
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed