Effects of Different Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Thyroidectomy

The Second People's Hospital of Huai'an

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Thyroid Diseases

Treatments: Drug: Dexmedetomidine (DEX); Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07622355

0009-0001-3762-5246

Details and patient eligibility

About

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.

Full description

This randomized controlled trial was conducted to evaluate the effects of different administration routes of dexmedetomidine on postoperative sleep quality in patients undergoing thyroidectomy. A total of 120 patients were randomized into three groups in a 1:1:1 ratio using computer-generated randomization and sealed opaque envelopes.

IN-D group: Intranasal dexmedetomidine plus intravenous placebo. A fixed dose of 100 μg dexmedetomidine was administered intranasally via alternating nostrils 30 minutes before surgery, with an equal volume of 0.9% saline infused intravenously.

IV-D group: Intravenous dexmedetomidine plus intranasal placebo. A loading dose of dexmedetomidine 0.5 μg/kg was infused intravenously over 10 minutes 30 minutes preoperatively, with an equal volume of 0.9% saline administered intranasally.

Control group: Intranasal and intravenous placebo (0.9% saline in both routes). Patients, attending anesthesiologists, and outcome assessors were blinded to group allocation throughout the study. Intraoperative anesthesia management was performed by a separate anesthesiologist not involved in data assessment to maintain blinding. All patients fasted for 6 hours and restricted clear fluids for 2 hours preoperatively. No premedication was administered.

Upon arrival in the operating room, standard monitoring was applied, including electrocardiography (ECG), pulse oximetry (SpO₂), and non-invasive blood pressure (NIBP). Invasive arterial cannulation was performed for continuous blood pressure monitoring.

General anesthesia was induced with etomidate 0.2 mg/kg, rocuronium 0.6 mg/kg, sufentanil 0.5 μg/kg, and propofol 1.5 mg/kg. After 5 minutes of preoxygenation, tracheal intubation was performed under video laryngoscopy. Mechanical ventilation was initiated with pure oxygen at 2.0 L/min, with tidal volume 6-8 mL/kg, I:E ratio 1:2, and PETCO₂ maintained at 35-45 mmHg. Correct positioning of the neuromonitoring endotracheal tube was verified after intubation.

Anesthesia depth was maintained at an entropy index (RE/SE) of 40-60 by adjusting infusions of propofol and remifentanil and the concentration of sevoflurane. Hemodynamic stability was maintained using vasoactive agents (ephedrine, phenylephrine, nitroglycerin) as needed.

All anesthetics were stopped at skin closure. Patients were transferred to the post-anesthesia care unit (PACU) immediately after surgery. Tracheal extubation was performed when patients recovered consciousness and adequate spontaneous respiration.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Dexmedetomidine Nasal Spray Group

Experimental group

Description:

Thirty minutes before surgery, 100 μg dexmedetomidine nasal spray was administered via alternating bilateral nostrils, with an equal volume of 0.9% normal saline pumped intravenously simultaneously.

Treatment:

Drug: Dexmedetomidine (DEX)

Drug: Dexmedetomidine (DEX)

Dexmedetomidine Intravenous Group

Experimental group

Description:

Thirty minutes before surgery, dexmedetomidine 0.5 μg/kg is administered intravenously as a 10-minute loading dose, with an equal volume of 0.9% normal saline given via nasal spray simultaneously.

Treatment:

Drug: Dexmedetomidine (DEX)

Drug: Dexmedetomidine (DEX)

Control Group

Placebo Comparator group

Description:

An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.

Treatment:

Drug: Saline