Sleep disorder
Conditions
Interventions
Group B:Dexmedetomidine at a dose of 0.2 to 0.7µg/kg/h was continuously intravenously pumped from 22:00 on the day of the operation to 06:00 the next day.
Group A:Continuously intravenously pump remimazolam at a dose of 0.1 to 0.3mg/kg/h from 22:00 on the day of the operation to 06:00 the next day.
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 to 80 years. 2.Patients with maxillofacial tumors who are considered to be at high risk of severe airway complications postoperatively and therefore undergo intraoperative tracheostomy. 3.Patients requiring postoperative mechanical ventilation and admission to the ICU for monitoring. 4.Possession of basic communication skills preoperatively, enabling cooperation in completing relevant scale assessments (e.g., PSQI, MMSE). 5.The subject or their legal representative has fully understood the study content and provided written informed consent.
Exclusion criteria
Exclusion criteria: 1.ASA classification >= IV. 2.Comorbid severe cardiac, hepatic, or renal insufficiency (as determined by the investigator, the risk associated with long-term use of sedative medications is deemed unacceptable). 3.History or current presence of severe psychiatric illness, severe central nervous system disorders, or severe preoperative cognitive impairment that precludes effective communication and scale assessment. 4.Clear history of allergy to remimazolam, dexmedetomidine, or related excipients. 5.Pregnant or lactating women. 6.Preoperative use of investigational drugs in other clinical trials without completing the required washout period. 7.Any other condition deemed by the investigator as potentially affecting trial safety or interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NREM duration;Total sleep time;Sleep efficiency;REM duration;Frequency and total duration of wake after sleep onset;Sleep fragmentation index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Richards-Campbell Sleep Questionnaire score;Average oxygen saturation;Mini-Mental State Examination score;Telephone Interview for Cognitive Status-Modified score;Self-Rating Anxiety Scale score;apnea-hypopnea index;Numeric Rating Scales Score;Inflammatory factors;Pittsburgh Sleep Quality Index;Adverse event; | — |
Countries
China
Contacts
Public ContactLuo Mengqiang, Lu Yi
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed