Effects of Different Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Thyroidectomy
2026. szeptember 8. frissítette: Zhu Guoying, The Second People's Hospital of Huai'an
Effects of Different Preoperative 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
120
Fázis
- 2. fázis
- 1. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Huai'an, Kína
- The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital, Huaian
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion criteria:
- Aged 18-65 years;
- ASA physical status classification I-II;
- BMI ranging from 18 to 30 kg/m²;
- Scheduled for general anesthesia thyroidectomy for benign or malignant thyroid lesions;
- No history of sedative or hypnotic medication within one week before surgery.
Exclusion Criteria:
- History of sleep disturbance or psychiatric disorders;
- Use of antidepressants, hypnotics or other sleep affecting medications;
- Allergy to dexmedetomidine;
- Nasal lesions or intolerance to intranasal spray administration;
- Severe cardiac conduction block, bradycardia or hypotension;
- Pregnant or lactating patients;
- Complicated with severe dysfunction of heart, liver, brain, kidney or other organs;
- Difficult airway encountered during anesthesia induction requiring modification of routine intubation strategy.o need to change the conventional intubation method
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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.
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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.
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.
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Placebo Comparator: Control Group
An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.
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An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.
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Kísérleti: Dexmedetomidine Nasal Spray Group
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.
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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.
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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Richards-Campbell Sleep Questionnaire（RCSQ）
Időkeret: Postoperative day 0
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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).
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Postoperative day 0
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Visual Analog Scale（VAS）
Időkeret: 6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
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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).
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6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
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Richmond Agitation and Sedation Scale(RASS)
Időkeret: 6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
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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.
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6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
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Drug use
Időkeret: Perioperative
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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).
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Perioperative
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Richards-Campbell Sleep Questionnaire（RCSQ）
Időkeret: Preoperative day 1，Postoperative day 1，Postoperative day 7
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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).
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Preoperative day 1，Postoperative day 1，Postoperative day 7
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The sleep data recorded by the Fitbit Charge 6 bracelet
Időkeret: Preoperative day 1，Postoperative day 0，Postoperative day 1
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The sleep data recorded by the Fitbit Charge 6 bracelet includes total sleep duration, wake time, deep sleep duration .
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Preoperative day 1，Postoperative day 0，Postoperative day 1
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The Quality of Recovery-15（QoR-15）
Időkeret: Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7
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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.
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Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7
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Hemodynamic indicators
Időkeret: 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).
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The perioperative blood pressure, heart rate (HR) and mean arterial pressure (MAP) are important hemodynamic indicators for evaluating the patient's perioperative condition.
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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).
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Time
Időkeret: Perioperative
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emergence time, PACU stay duration and hospital length-of-stay were recorded.
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Perioperative
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Adverse Reaction
Időkeret: 48 Hours After Surgery
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Record adverse reactions such as hypotension, bradycardia, nausea and vomiting, dizziness, hoarseness, postoperative hemorrhage, dysphagia, xerostomia, and nasal dryness.
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48 Hours After Surgery
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Nyomozók
- Kutatásvezető: Jun Wang, The Second People's Hospital of Huai'an
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2026. január 5.
Elsődleges befejezés (Tényleges)
2026. június 30.
A tanulmány befejezése (Tényleges)
2026. június 30.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. május 13.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 27.
Első közzététel (Tényleges)
2026. június 3.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. szeptember 11.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. szeptember 8.
Utolsó ellenőrzés
2026. szeptember 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 0009-0001-3762-5246
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
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Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
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