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

27. Mai 2026 aktualisiert von: Zhu Guoying, The Second People's Hospital of Huai'an

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

120

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: 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.
Arzneimittel: 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.
Arzneimittel: 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.
Arzneimittel: 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-Komparator: Control Group
An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.
Arzneimittel: Saline
An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Richards-Campbell Sleep Questionnaire（RCSQ）
Zeitfenster: Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pittsburgh Sleep Quality Index（PSQI）
Zeitfenster: Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge
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
Zeitfenster: Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge
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）
Zeitfenster: 6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
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)
Zeitfenster: 6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
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）
Zeitfenster: Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge
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
Zeitfenster: Perioperative
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
Zeitfenster: 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
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
Zeitfenster: Perioperative
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
Zeitfenster: Perioperatively and Through 48 Hours After Surgery
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Second People's Hospital of Huai'an

Ermittler

  • Hauptermittler: Jun Wang, The Second People's Hospital of Huai'an

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. September 2025

Primärer Abschluss (Geschätzt)

30. Juni 2026

Studienabschluss (Geschätzt)

31. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 0009-0001-3762-5246

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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