Insomnia
Conditions
Interventions
High-dose trial group:Intranasal dexmedetomidine spray:1.5µg/kg
Low-dose trial group:Intranasal dexmedetomidine spray:1µg/kg
Placebo control group:Equal-volume administration of dexmedetomidine nasal spray placebo
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects have fully understood the purpose, procedures and potential adverse reactions of this study, voluntarily participate in the clinical study and provide written informed consent, are able to complete the entire study process in accordance with the requirements and comply with the study regulations. 2. No gender restriction; at screening: aged 18–65 years, BMI 18–30 kg/m^2, hospitalized patients scheduled for thoracoscopic lobectomy, segmentectomy or wedge resection (excluding thoracotomy and combined laparoscopic surgery). 3. Had a sleep onset latency > 30 minutes for at least 3 days in the past week and had a demand for sleep improvement, or with an Insomnia Severity Index (ISI) score > 7. 4. Blood oxygen saturation (SpO2) > 95% while breathing room air. 5. Numeric Rating Scale (NRS) pain score < 3 at enrollment.
Exclusion criteria
Exclusion criteria: 1. Severe hepatic and renal insufficiency, etc. 2. Study participants deemed unsuitable for intranasal administration by the investigator (e.g., those with severe rhinitis, nasal malformation, etc.). 3. Use of psychotropic drugs or a2-adrenergic receptor agonists within the past two weeks. 4. Confirmed or suspected obstructive sleep apnea syndrome. 5. Study participants with a history of myocardial infarction or unstable angina pectoris within 6 months prior to the screening period. 6. Study participants with a heart rate < 60 beats per minute during the screening period, or a history of sick sinus syndrome, second-degree (or higher) atrioventricular block without pacemaker implantation, or cardiac insufficiency preoperatively. 7. Study participants with a history of ischemic stroke or transient ischemic attack. 8. Study participants with poorly controlled blood pressure despite pharmacotherapy (hypertension: systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg; hypotension: systolic blood pressure < 90 mmHg and/or diastolic blood pressure = 50 mmHg). 9. Study participants with psychiatric disorders (e.g., schizophrenia, depression, etc.) and cognitive dysfunction, a history of epilepsy, or a history of abuse of psychotropic drugs or anesthetic agents. 10. Study participants with a history of difficult airway or potential difficult airway, such as those with obstructive sleep apnea syndrome. 11. Individuals with a history of allergy to multiple substances or to the ingredients or components of study drugs including dexmedetomidine. 12. Pregnant or lactating females; individuals planning to conceive within 30 days prior to screening to 6 months after study completion, or who are unwilling or unable to use effective contraceptive measures. 13. Individuals with other factors deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leeds Sleep Evaluation Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Hamilton Anxiety Rating Scale;Confusion Assessment Method;Richmond Agitation-Sedation Scale;Numeric Rating Scale for Sleep Satisfaction;Withdrawal Reaction Assessment;Vital signs;Numeric Rating Scale for Pain;Pittsburgh Sleep Quality Index;Numeric Rating Scale for Satisfaction During Hospitalization; | — |
Countries
China
Contacts
Public ContactLiu Lunxu
West China Hospital, Sichuan University
Outcome results
None listed