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Comparison of efficacy and safety of dexmedetomidine nasal drip and oral Lorazepam in the treatment of preoperative anxiety and insomnia

Comparison of efficacy and safety of dexmedetomidine nasal drip and oral Lorazepam in the treatment of preoperative anxiety and insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067165
Enrollment
Unknown
Registered
2022-12-28
Start date
2023-01-01
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

Right metformin group:Dexmedetomidine nasal drip + oral vitamin C
Lorazepam group:Saline nasal drip + oral lorazepam
Placebo group:Saline nasal drip + oral 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: a. ASA classification I to II b. Hospital Anxiety and Depression Scale (anxiety component) HADS-A > 7 points c. Insomnia Severity Index (ISI) >7 points d. Patients with oxygen saturation of 95% or more on air inhalation e. Patients 18-65 years of age, regardless of gender, who are to undergo elective surgery f. Voluntary signed informed consent

Exclusion criteria

Exclusion criteria: a. Hospital Anxiety and Depression Scale (depression component) HADS-D > 7 b. NRS pain score = 7. c. Presence of alcohol or drug dependence d. use of psychotropic drugs within 1 week prior to enrollment e. BMI > 30kg/m2 f. patients with confirmed or suspected presence of apnea syndrome g. Presence of any intranasal lesions or congenital abnormalities in the nose. h. Abnormalities in ECG, liver and kidney function. i. History of allergy to the drugs used in the study. j. Pregnancy, lactation and plans to become pregnant in the short term. k. Those who are unable to understand the content of the relevant scale or have 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.com15946997288

Outcome results

None listed

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