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

Effects of Different Perioperative Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Thyroidectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thyroid Diseases
• Intervention / Treatment: Drug: Dexmedetomidine (DEX); Drug: Dexmedetomidine (DEX); Drug: Saline

Detailed 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. Dexmedetomidine 1.0 μg/kg (maximum 100 μg) 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Huai'an, China
    • The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital, Huaian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine Nasal Spray Group; Thirty minutes before surgery, 1.0 μg/kg of dexmedetomidine nasal spray (adult dosage, maximum dose not exceeding 100 μg) is administered by alternating bilateral nasal inhalation. Meanwhile, an equal volume of 0.9% normal saline is infused via intravenous pump.	Drug: Dexmedetomidine (DEX); Thirty minutes before surgery, 1.0 μg/kg of dexmedetomidine nasal spray (adult dosage, maximum dose not exceeding 100 μg) is administered by alternating bilateral nasal inhalation. Meanwhile, an equal volume of 0.9% normal saline is infused via intravenous pump.; Drug: Dexmedetomidine (DEX); 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.
Experimental: Dexmedetomidine Intravenous Group; 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.	Drug: Dexmedetomidine (DEX); Thirty minutes before surgery, 1.0 μg/kg of dexmedetomidine nasal spray (adult dosage, maximum dose not exceeding 100 μg) is administered by alternating bilateral nasal inhalation. Meanwhile, an equal volume of 0.9% normal saline is infused via intravenous pump.; Drug: Dexmedetomidine (DEX); 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.
Placebo Comparator: Control Group; An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.	Drug: Saline; An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richards-Campbell Sleep Questionnaire（RCSQ）	This scale was developed by Richards et al. It is a simple self-report scale specifically designed for ICU patients, widely used in sleep assessment research in critical care medicine and post-anesthesia fields. The RCSQ includes 6 items: the first 5 are core scoring items, assessing sleep depth, difficulty in falling asleep, number of awakenings, ability to fall back asleep, and overall sleep quality respectively; the 6th is an environmental noise assessment item (not included in the total score, only for reference). Each core item uses a 100 mm Visual Analog Scale (VAS): the left end is 0 points (worst state), the right end is 100 points (best state), and the score is the distance from the left end to the subject's marked position. The total score is the arithmetic mean of the 5 core items (range 0-100 points), with higher scores indicating better sleep. Clinical grading: <50 points (poor), 50-69 points (moderate), ≥70 points (good).	Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index（PSQI）	The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire used to assess sleep quality and sleep disorders. It consists of 19 self-reported questions and is used to calculate seven dimensions of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep-inducing drugs, and daytime functional impairment. Each component is scored on a 0-3 scale, and the total score is the sum of the seven dimensions (ranging from 0 to 21 points). A total score greater than 5 points indicates the presence of sleep disorders, and the higher the score, the worse the sleep quality.	Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge
The sleep data recorded by the Fitbit Charge 6 bracelet	The sleep data recorded by the Fitbit Charge 6 bracelet includes sleep timeline, awake time, rapid eye movement (REM) sleep, light sleep, deep sleep, and sleep score.	Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge
Visual Analog Scale（VAS）	The Visual Analog Scale (VAS) is a tool used to assess the intensity of subjective symptoms (such as pain, itching, anxiety, etc.). Through a line of fixed length (usually 10 cm), patients mark the severity of their current symptoms based on their own feelings. The scale is a horizontal straight line, with "no symptoms" (0 points) marked at one end and "the most severe symptoms" (10 points) at the other end. Patients mark a position on the line that matches their symptoms, and the rater measures the distance from the starting point to the marked position, which is converted into a score ranging from 0 to 10 points. A score of 0 means no symptoms at all (e.g., no pain), 1-3 points indicate mild symptoms (not affecting daily life), 4-6 points indicate moderate symptoms (affecting life but tolerable), and 7-10 points indicate severe symptoms (intolerable and requiring urgent intervention).	6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
Richmond Agitation and Sedation Scale(RASS)	The Richmond Agitation-Sedation Scale (RASS) is a widely used tool to assess the level of sedation and agitation in patients. It ranges from +4 to -5, with specific descriptors for each score: +4 indicates combative behavior; +3 is extremely agitated; +2 means agitated and restless ; +1 denotes restless but calm; 0 represents alert and calm; -1 is drowsy; -2 indicates light sedation; -3 means moderate sedation; -4 is deep sedation ; and -5 represents unarousable. This scale helps clinicians objectively evaluate and adjust sedation levels to ensure patient comfort and safety.	6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
The Quality of Recovery-15（QoR-15）	The QoR-15 scale is divided into five dimensions: physical comfort (5 items), self-care (2 items), psychological support (2 items), emotional state (4 items), and pain (2 items), with each item rated on a scale of 0-10, and the total score ranging from 0-150, with the higher the score the better the quality of recovery, and a score of 118 and above indicating surgery.	Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge
Drug use	Record the intraoperative consumption of propofol and remifentanil, the names and dosages of intraoperative vasoactive drugs, and the postoperative consumption of rescue analgesics (including PACU).	Perioperative
Hemodynamic indicators	The perioperative blood pressure, heart rate (HR) and mean arterial pressure (MAP) are important hemodynamic indicators for evaluating the patient's perioperative condition.	Baseline，Pre-Intervention ，Before Intubation，Immediately After Intubation，5 Minutes After Intubation，At the Time of Skin Incision，30 Minutes After the Start of Surgery，At the End of Surgery，Before Extubation，At PACU Discharge
Time	Record the duration of surgery, awakening time (the time from the cessation of anesthetics to the patient's spontaneous eye opening), extubation time (the time from the cessation of anesthetics to the patient's extubation), time of discharge from the PACU, and postoperative hospital stay.	Perioperative
Adverse Reaction	Record adverse reactions such as hypotension, bradycardia, nausea and vomiting, dizziness, sore throat, hoarseness, respiratory depression, bleeding, postoperative pain, dysphagia, tremor, facial nerve sign, Trousseau's sign, dry mouth, and dry nose.	Perioperatively and Through 48 Hours After Surgery

Collaborators and Investigators

• Sponsor: The Second People's Hospital of Huai'an
• Investigators: Principal Investigator: Jun Wang, The Second People's Hospital of Huai'an

Publications and helpful links

General Publications

• He J, Zhang X, Li C, Fu B, Huang Y, Li H. Dexmedetomidine nasal administration improves perioperative sleep quality and neurocognitive deficits in elderly patients undergoing general anesthesia. BMC Anesthesiol. 2024 Jan 30;24(1):42. doi: 10.1186/s12871-024-02417-9.
• Liu H, Wei H, Qian S, Liu J, Xu W, Luo X, Fang J, Liu Q, Cai F. Effects of dexmedetomidine on postoperative sleep quality: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Mar 21;23(1):88. doi: 10.1186/s12871-023-02048-6.
• Wang L, Liang XQ, Sun YX, Hua Z, Wang DX. Effect of perioperative dexmedetomidine on sleep quality in adult patients after noncardiac surgery: A systematic review and meta-analysis of randomized trials. PLoS One. 2024 Dec 5;19(12):e0314814. doi: 10.1371/journal.pone.0314814. eCollection 2024.
• Wu J, Liu X, Ye C, Hu J, Ma D, Wang E. Intranasal dexmedetomidine improves postoperative sleep quality in older patients with chronic insomnia: a randomized double-blind controlled trial. Front Pharmacol. 2023 Nov 16;14:1223746. doi: 10.3389/fphar.2023.1223746. eCollection 2023.
• Maras Baydogan G, Surme Y, Kutuk Karasungur S. The challenges experienced by patients in the early period after thyroidectomy and the effects on sleep quality. Support Care Cancer. 2025 May 1;33(5):438. doi: 10.1007/s00520-025-09483-w.
• Koo DL, Park Y, Nam H, Chai YJ. Sleep quality of patients with papillary thyroid carcinoma: a prospective longitudinal study with 5-year follow-up. Sci Rep. 2022 Nov 5;12(1):18823. doi: 10.1038/s41598-022-23549-3.
• Wang Y, Jin Z, Xu W, Chen K, Wei L, Yang D, Deng X, Tong S. Clinical observation of dexmedetomidine nasal spray in the treatment of sleep disorders on the first night after undergoing maxillofacial surgery: a single-center double-blind randomized controlled study. J Pharm Pharm Sci. 2023 Oct 3;26:11699. doi: 10.3389/jpps.2023.11699. eCollection 2023.
• Li X, Yan L, Wang L, Chen H, Yang B. Study on the preventive effect of dexmedetomidine on anesthetic associated sleep disturbance in young to middle-aged female patients undergoing hysteroscopy: a study protocol for a crossover randomized controlled trial. Trials. 2024 Jul 15;25(1):480. doi: 10.1186/s13063-024-08311-6.
• Yang WY, Huang K, Lin ZJ, Zeng W, Liu X, Liu HB, Zhong ML, Wei J, Liang WD, Wang LF, Chen L. Intranasal Dexmedetomidine for the Management of Preoperative Anxiety-Related Insomnia: A Randomized, Three-Blinded, Clinical Trial Compared with Lorazepam and Placebo. Drug Des Devel Ther. 2024 Dec 17;18:6061-6073. doi: 10.2147/DDDT.S487463. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexmedetomidine; Sodium Chloride
• Other Study ID Numbers: 0009-0001-3762-5246

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No