Status:
UNKNOWN
Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders
Lead Sponsor:
Xiangya Hospital of Central South University
Conditions:
Sleep Disorder
Eligibility:
All Genders
60-85 years
Phase:
PHASE4
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 qua...
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 postoperativ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2023
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT05325762
Start Date
December 1 2022
End Date
December 25 2023
Last Update
October 3 2022
Active Locations (4)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
2
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
3
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110000
4
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000