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

NCT07622355 | Active Not Recruiting Phase 1

• 1 other identifier: 0009-0001-3762-5246
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pittsburgh Sleep Quality Index（PSQI）

  Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge

• The sleep data recorded by the Fitbit Charge 6 bracelet

  Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge

• Visual Analog Scale（VAS）

  6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative

• Richmond Agitation and Sedation Scale(RASS)

  6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative

• The Quality of Recovery-15（QoR-15）

  Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7，Pre-discharge

Study Arms (3)

Dexmedetomidine Nasal Spray Group

EXPERIMENTAL

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)

Dexmedetomidine Intravenous Group

EXPERIMENTAL

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)

Control Group

PLACEBO COMPARATOR

An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.

Drug: Saline

Interventions

Dexmedetomidine (DEX) DRUG

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.

Dexmedetomidine Nasal Spray Group

Saline DRUG

An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second People's Hospital of Huai'an: lead

Study Sites (1)

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

Huai'an, China

Location

Related Publications (9)

• 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.

  PMID: 39636906 BACKGROUND

• 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.

  PMID: 40307526 BACKGROUND

• 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.

  PMID: 36335214 BACKGROUND

• 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.

  PMID: 36944937 BACKGROUND

• 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.

  PMID: 37854323 BACKGROUND

• 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.

  PMID: 38291398 BACKGROUND

• 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.

  PMID: 38034987 BACKGROUND

• 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.

  PMID: 39010171 BACKGROUND

• 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.

  PMID: 39717197 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jun Wang

  The Second People's Hospital of Huai'an

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization sequence was generated by a computer and handed over in sealed opaque sequentially numbered envelopes. The envelope was opened by anaesthetist not involved in the study and drugs were dispensed as per the allocation card. The configured drugs were then handed over to experienced anaesthetists who were not aware of the subgroups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 3, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-05

Locations

CN (1)