A Phase 1/2 interventional study of Dexmedetomidine (DEX) and Dexmedetomidine (DEX) in Thyroid Diseases, sponsored by The Second People's Hospital of Huai'an. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by The Second People's Hospital of Huai'an · Phase 1/2, Interventional, and Treatment
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.
Group A (intranasal DEX group): 100 μg dexmedetomidine was administered via intranasal spray 30 min before surgery (alternating sprays into bilateral nasal cavities), accompanied by intravenous infusion of an equal volume of normal saline. Group B (intravenous DEX group): Dexmedetomidine 0.5 μg/kg was intravenously infused 30 min before surgery with a 10 minute intravenous loading infusion, together with intranasal spray of an equal volume of normal saline. Group C (control group): An equal volume of normal saline was administered via both intranasal spray and intravenous route 30 min before surgery.
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 received routine preoperative fasting and fluid deprivation. After entering the operating room, peripheral venous access was established and invasive arterial puncture was performed. Electrocardiography (ECG), pulse oxygen saturation (SpO₂), non invasive blood pressure (NIBP), invasive blood pressure (IBP), and bispectral index (BIS) were monitored.General anesthesia was induced with rocuronium 0.6 mg/kg, sufentanil 0.5 μg/kg, and propofol 1.5 mg/kg. Following induction, tracheal intubation was performed under video laryngoscopy, and the patient was connected to an anesthesia machine for mechanical ventilation. Ventilator settings: controlled ventilation with pure oxygen at 2.0 L/min, tidal volume 6-8 ml/kg, inspiratory-to-expiratory ratio 1:2, to maintain end-tidal carbon dioxide (PetCO₂) at 35-45 mmHg (1 mmHg = 0.133 kPa). During surgery, intravenous infusions of propofol (4-12 mg·kg-¹·h-¹) and remifentanil (0.2-0.4 μg·kg-¹·min-¹) were used to maintain appropriate depth of anesthesia (BIS maintained between 40 and 60). Vasopressor agents such as ephedrine and phenylephrine were administered according to intraoperative conditions. Immediately after the operation, patients were transferred to the post-anesthesia care unit (PACU). The tracheal tube was removed once consciousness and respiration recovered satisfactorily. Ketorolac tromethamine injection was administered for rescue analgesia when postoperative pain rescue was required.
967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 544 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →The Second People's Hospital of Huai'an is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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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.
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.
Drug: Dexmedetomidine (DEX)
An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.
Drug: Saline
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.
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: Postoperative day 0
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 1，Postoperative day 7
The sleep data recorded by the Fitbit Charge 6 bracelet
The sleep data recorded by the Fitbit Charge 6 bracelet includes total sleep duration, wake time, deep sleep duration .
Time frame: Preoperative day 1，Postoperative day 0，Postoperative day 1
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
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: on operating room admission (T0), immediately before intubation (T1), immediately after intubation (T2), at skin incision (T3), 30 min after surgical commencement (T4), at the end of surgery (T5), and immediately before extubation (T6).
Time
emergence time, PACU stay duration and hospital length-of-stay were recorded.
Time frame: Perioperative
Adverse Reaction
Record adverse reactions such as hypotension, bradycardia, nausea and vomiting, dizziness, hoarseness, postoperative hemorrhage, dysphagia, xerostomia, and nasal dryness.
Time frame: 48 Hours After Surgery
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The Second People's Hospital of Huai'an