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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
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.
An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.
The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital, Huaian
Huai'an, China
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).
Time frame: Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Perioperatively and Through 48 Hours After Surgery
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