Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders

NCT05325762 | Unknown Phase 4

• 1 other identifier: XiangyaH1
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 4

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.

Conditions

Sleep Disorder

Keywords

Sleep Disorder; Propofol; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Sleep improvement efficiency

  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.

  Preoperative, postoperative 1-7 days, postoperative 30 days

Secondary Outcomes (2)

• Safety of drug use

  The first night after surgery

• Sleep scale assessment

  Preoperative, postoperative 1-7 days, postoperative 30 days

Study Arms (3)

Propofol

EXPERIMENTAL

Drug: Propofol

Dexmedetomidine

ACTIVE COMPARATOR

Drug: Dexmedetomidine

saline

PLACEBO COMPARATOR

Drug: Saline

Interventions

Propofol DRUG

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.

Propofol

Dexmedetomidine DRUG

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.

Dexmedetomidine

Saline DRUG

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.

saline

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (4)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Propofol; Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

e wang, M.D.

CONTACT

18874889950; ewang324@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were evaluated with MOAA/S by intravenous administration of propofol, dexmedetomidine, or normal saline until successful sleep (MOAA/S≤2)

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: April 13, 2022
• Study Start: December 1, 2022
• Primary Completion: October 25, 2023
• Study Completion: December 25, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-02

Locations

CN (4)