Clinical trial NCT05325762: Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders
Official title: Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders: a Multicentre, Randomized, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Disorder
Keywords: Sleep Disorder
Propofol
Dexmedetomidine
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 321
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were evaluated with MOAA/S by intravenous administration of propofol, dexmedetomidine, or normal saline until successful sleep (MOAA/S≤2)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep improvement efficiency
timeFrame: Preoperative, postoperative 1-7 days, postoperative 30 days
Secondary outcomes:
measure: Safety of drug use
timeFrame: The first night after surgery
measure: Sleep scale assessment
timeFrame: Preoperative, postoperative 1-7 days, postoperative 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: