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Therapeutic Efficacy of Dexmedetomidine-Propofol Induced Sleep Regulation Therapy in Patients with Insomnia and Comorbid Anxiety-Depression: A Randomized Controlled Trial

Therapeutic Efficacy of Dexmedetomidine-Propofol Induced Sleep Regulation Therapy in Patients with Insomnia and Comorbid Anxiety-Depression: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109339
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-09-20
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Conventional treatment + anesthesia induction sleep balance group:On the basis of conventional treatment, dexmedetomidine combined with propofol was used to induce sleep balance
Conventional treatment group:Conventional treatment

Sponsors

The First People's Hospital of Zunyi
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age above 18 years, both males and females are eligible; 2.Meet the diagnostic criteria for insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5); 3.Total score of the Pittsburgh Sleep Quality Index (PSQI) > 7; 4.Presence of anxiety or depressive symptoms, indicated by a Hamilton Anxiety Scale (HAMA) score >=14 and =7 and <=23, without meeting the full diagnostic criteria for an anxiety or depressive disorder; 5.Voluntarily participate in the treatment and have provided signed informed consent;

Exclusion criteria

Exclusion criteria: 1.Allergy to dexmedetomidine or propofol; 2.Presence of cardiac conduction block, severe ventricular dysfunction, severe hepatic or renal insufficiency, or other serious somatic diseases; 3.Abnormal blood pressure, bradycardia, or poorly controlled diabetes mellitus; 4.Detection of sleep apnea through polysomnography (PSG) conducted prior to treatment; 5.History of head trauma; 6.History of epilepsy, psychiatric disorders, or abnormal electroencephalogram (EEG) findings; 7.Known history of alcohol abuse or substance misuse; 8.Pregnancy, lactation, or planned pregnancy; 9.Educational level below elementary school or inability to comprehend the content of the rating scales used before and after treatment;

Design outcomes

Primary

MeasureTime frame
Quality of sleep;Anxiety and depression score;

Secondary

MeasureTime frame
Patients' experience scores regarding the induction process.;Multi-omics testing;Hyperarousal condition;Vital signs;Adverse reactions;Blood biomarkers;Quality of sleep;Clinical efficacy;Structure of sleep;

Countries

China

Contacts

Public ContactXiong Liulin

The First People's Hospital of Zunyi

499465010@qq.com+86 851 2860 8507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026