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Dexmetomidine nasal drip induced sleep in the treatment of anxiety insomnia before operation: a ranomized controlled trial.

Dexmetomidine nasal drip induced sleep in the treatment of anxiety insomnia before operation: a ranomized controlled trial.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044747
Enrollment
Unknown
Registered
2021-03-26
Start date
2021-03-29
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

insomnia

Interventions

Treatment group:Therapy by Dexmedetomidine
Control group:Isometric saline drops

Sponsors

The First Affiliated Hospital of Gannan Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.After understanding the contents of the study, voluntarily join and sign the informed consent form. 2.(HADS) score of Hospital anxiety and Depression scale >= 11. 3.Insomnia severity Index scale > 7 points. 4.The patient's cardiopulmonary function was good, and the oxygen saturation of inhaled air was more than 95%. There was no obvious taboo. 5.Patients aged between 18 and 60 years, regardless of sex, who intend to undergo elective surgery. 6.BMI < 30kg/m2. 7.American Association of Anesthesiologists (ASA) Grade I ~ II. 8.The patients in the group are required to have a degree above the primary school education level and can cooperate to complete the scale test.

Exclusion criteria

Exclusion criteria: 1.Obese, short neck; 2.Severe somatic symptoms; 3.Alcohol and drug addicts; 4.Used antidepressants and psychiatric drugs one week before entering the group; 5.People who are known to be allergic to dexmetomidine or other drugs used in this study; 6.Patients with severe cardiac conduction block, sinus bradycardia and severe decompensation of cardiac function; 7.Patients with severe liver dysfunction whose AST and / or ALT exceed the upper limit of the normal value, and patients whose creatinine and / or urea nitrogen exceed the upper limit of the normal value; 8.Pregnant and breast-feeding women; 9.People with severe dehydration and severe malnutrition.

Design outcomes

Secondary

MeasureTime frame
Oxygen saturation;Heart rate;

Primary

MeasureTime frame
Hospital Anxiety and Depression Scale score;Insomnia severity Index scale;The Observer's Assessment of Alertness/Sedation Scale;

Countries

China

Contacts

Public ContactChen Li

Gannan Medical University

zgx8778@126.com+86 15727752168

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026