Sleep Disorder
Conditions
Keywords
Sleep Disorder, Propofol, Dexmedetomidine
Brief summary
This study intends to conduct postoperative sleep intervention for elderly patients with sleep disorders undergoing surgery. We hope to explore whether propofol can improve the postoperative sleep quality of elderly patients with sleep disorders, prevent the occurrence of postoperative delirium in elderly patients, relieve patients' pain, promote patients' postoperative rehabilitation, and provide reference for realizing the rapid rehabilitation of elderly patients with sleep disorders through intravenous administration of research drugs, on the premise of improving patient comfort and ensuring patient safety.
Detailed description
The purpose of this multicenter, randomized, controlled clinical study was to evaluate the efficacy and safety of propofol compared with normal saline and dexmedetomidine in the effect of postoperative sleep quality in elderly subjects with sleep disorders. Subjects were randomly assigned to propofol group, dexmedetomidine group or normal saline control group. Propofol group: At 21:00 on the night of tracheal extubation, propofol was administered intravenously. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration.Dexmedetomidine group: treated with dexmedetomidine at 21 PM on the day of tracheal extubation. During administration, patients were evaluated with MOAA/S every 2min. Normal saline control group: 21 on the night of tracheal extubation: Normal saline was injected intravenously at the rate of 0.5ml/(kg.h) beginning at 00. During the administration, patients were evaluated with MOAA/S every 2min. The effect of drugs on sleep improvement was evaluated by subjective scale and objective electrical monitoring.
Interventions
DRUGPropofol
At 21:00 on the night of tracheal extubation, propofol was administered intravenously with a microinjection pump for 2min. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration.
DRUGDexmedetomidine
Dexmedetomidine was at 21 PM on the day of tracheal extubation: Dexmedetomidine was injected intravenously beginning at 00. During administration, patients were evaluated with MOAA/S every 2min.
DRUGSaline
At 21:00 PM on the day of tracheal extubation, normal saline was injected intravenously. During the administration, patients were evaluated with MOAA/S every 2 minutes.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The blind group included the principal investigator, and any other participants in the recording, evaluation, analysis, or review of efficacy/safety endpoint data, who were primarily responsible for study operations other than drug administration (e.g., subject screening, efficacy and safety indicator recording, statistical analysis, etc.).
Intervention model description
Patients were evaluated with MOAA/S by intravenous administration of propofol, dexmedetomidine, or normal saline until successful sleep (MOAA/S≤2)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age ≥ 60 years old * Chronic insomnia * Pittsburgh Sleep Quality Index\>5 points * Daytime functional impairment (component Ⅶ ≥2 points in PSQI) * Patients undergoing elective surgery * Patients to be admitted to ICU after surgery * Voluntarily participate in the study and sign the informed consent
Exclusion criteria
* Subjects with severe hemodynamic instability * Subjects with difficult airway * Patients with other sleep disorders (including sleep apnea syndrome, exercise-related sleep disorders and other types of sleep disorders) * Subjects requiring sedation, mechanical ventilation, or sleep prior to medication; * Severe liver dysfunction (Child-Pugh GRADE C) * Severe renal dysfunction (requiring dialysis before surgery) * Patients with allergies to study drugs and related ingredients * Patients with severe dementia, low cognitive function, language impairment, severe hearing or vision impairment, mental disorder, coma and other conditions cannot complete the assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep improvement efficiency | Preoperative, postoperative 1-7 days, postoperative 30 days | The total score of The Leeds Sleep Evaluation Questionaire was \> 100 （The score ranges from 0 to 100， a higher scores mean a better outcome.）, the incubation period of sleep was \< 30min, the sleep duration was \> 5h, and the sleep quality was good. Assess changes at several points in time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of drug use | The first night after surgery | Adverse events and serious adverse events. |
| Sleep scale assessment | Preoperative, postoperative 1-7 days, postoperative 30 days | Preoperative and postoperative sleep was assessed using Pittsburgh sleep quality index. Assess changes at several points in time. |
Countries
China
Contacts
Primary Contacte wang, M.D.
Outcome results
None listed