Effects of Different Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in P… (NCT07622355) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Effects of Different Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Thyroidectomy
China120 participantsStarted 2025-09-01
Plain-language summary
Patients undergoing thyroid surgery often experience significant preoperative anxiety and show high concern about voice changes, scar formation and other related issues. Postoperative neck discomfort and dysphagia also tend to disrupt normal sleep. Dexmedetomidine activates α₂ receptors in the mesencephalic-pontine-medullary reticular formation, inhibits the release of norepinephrine, and induces a sleep state similar to non-rapid eye movement (NREM) sleep, particularly the N2 stage, which is closer to physiological sleep. This study aimed to explore the effects of intranasal spray versus intravenous administration of dexmedetomidine on postoperative sleep quality in patients undergoing thyroidectomy. By optimizing preoperative pharmacological intervention, it intends to improve patients' postoperative sleep quality, relieve pain and reduce postoperative adverse reactions, enhance recovery quality, and optimize patients' satisfaction and comfort level.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18-65 years old
* ASA classification: Grade I or II
* BMI: 18-30 kg/m²
* Planned to undergo thyroid benign tumor or thyroid malignant tumor resection under general anesthesia
* No history of sedatives or sleeping pills used within 1 week before surgery
* Agree to participate in the study and sign the informed consent form
Exclusion Criteria:
* History of sleep disorders or mental illness
* Use of sleep-affecting drugs such as antidepressants and sleeping pills
* Allergy to dexmedetomidine and other drugs
* Patients with nasal lesions or intolerance to nasal sprays
* Cardiac conduction block, severe bradycardia or hypotension
* Pregnant or lactating women
* Patients with severe dysfunction of the heart, brain, lungs, liver, kidneys or other organs
* Patients with difficult airway during anesthesia induction who need to change the conventional intubation method
* Patients who refuse to participate in this study and do not sign the informed consent form
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Richards-Campbell Sleep Questionnaire（RCSQ）
Timeframe: Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge