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Comparison of efficacy and safety of dexmedetomidine and zolpidem in the treatment of preoperative anxiety and insomnia

Comparison of efficacy and safety of dexmedetomidine and zolpidem in the treatment of preoperative anxiety and insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066200
Enrollment
Unknown
Registered
2022-11-28
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Anxiety insomnia

Interventions

Dexmedetomidine Group:Dexmedetomidine 2.5 ug/kg nasal drip plus oral tablet of insomnia function (vitamin C)
Zolpidem group:The patients were given 1/40 body weight saline nasal drops and 10 mg zolpidem orally
Placebo group:The patients' body weight was 1/40th of the volume of normal saline nasal drip plus oral tablet (vitamin C)

Sponsors

The first affiliated hospital of Gannan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. ASA classification I-II; 2. Hospital Anxiety and Depression Scale (anxiety component) HADS-A >= 7 points; 3. Insomnia severity index (ISI) >7 points; 4. Patients with oxygen saturation of 95% or more on air inhalation; 5. Patients 18-65 years of age, regardless of gender, who are to undergo elective surgery; 6. Voluntary signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Hospital Anxiety and Depression Scale (depression component) HADS-D >= 7 points 2.NRS pain score >= 7. 3. Presence of alcohol or drug dependence 4. use of psychotropic drugs within 1 week prior to enrollment 5. BMI > 30 kg/m^2 6. Patients with confirmed or suspected sleep apnea syndrome 7. Presence of any intranasal lesion or congenital abnormality in the nose. 8. Abnormal ECG, liver or kidney function. 9. History of allergy to the drugs used in the study. 10. Pregnancy, lactation, and plans to become pregnant in the short term. 11. Those who are unable to understand the content of the relevant scale or have a severe visual impairment.

Design outcomes

Primary

MeasureTime frame
Time to fall asleep;total sleep time;Psychomotor alertness tasks;Leeds sleep rating scale;

Secondary

MeasureTime frame
Sleep Quality Digital Rating Scale;mean arterial pressure;heart rate;Blood pressure saturation;adverse reaction;

Countries

China

Contacts

Public ContactLi Chen

The first affiliated hospital of Gannan Medical College

2496700057@qq.com+86 159 4699 7288

Outcome results

None listed

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