Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Thoracoscopic Lung Resection Patients
2026年5月6日 更新者：Peng Li、Sichuan Provincial People's Hospital
The Effect of Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Lung Resection
This clinical trial is designed to observe the effect of dexmedetomidine nasal spray on the incidence of postoperative delirium in elderly patients undergoing thoracoscopic lung resection.
Eligible elderly patients scheduled for thoracoscopic lung resection will be randomly divided into two groups: the dexmedetomidine group will receive dexmedetomidine hydrochloride nasal spray, while the placebo group will be administered an equivalent volume of placebo nasal spray.
The primary outcome is the incidence of postoperative delirium within 3 days after surgery.
Secondary outcomes include the severity and duration of delirium, as well as postoperative pain, subjective sleep quality, and the incidence of adverse events, which will be compared between the two groups to evaluate the safety and efficacy of dexmedetomidine nasal spray.
調査の概要
研究の種類
介入
入学 (推定)
264
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Peng LI
- 電話番号：+86 13668169590
- メール：lipengmazui@163.com
研究連絡先のバックアップ
- 名前：Shaomao Jia
- 電話番号：+86 13419213559
- メール：670979499@qq.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status II-III.
- Age ≥ 65 years, with no gender restriction.
- Patients scheduled for elective thoracoscopic lung resection under general anesthesia, with an expected operative duration of 1-4 hours.
- Body mass index (BMI) between 18 kg/m² and 30 kg/m².
Exclusion Criteria:
- Known hypersensitivity to dexmedetomidine hydrochloride or any of the excipients in the investigational product.
- Pre-existing nasal conditions, nasal surgery, or nasal allergies that may significantly impair nasal drug absorption (e.g., chronic nasal congestion, rhinorrhea, epistaxis, nasal anatomical abnormalities, or mucosal pathology affecting absorption).
- History of cranial trauma.
- Pre-existing diagnosis or clinical suspicion of neurocognitive impairment, defined as a Mini-Mental State Examination (MMSE) score < 24.
- History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
- History of alcohol or substance abuse/dependence.
- Left ventricular ejection fraction < 30%; sick sinus syndrome; severe sinus bradycardia (< 50 bpm); or second- or higher-degree atrioventricular block without permanent pacemaker implantation.
- History of myocardial infarction, unstable angina, severe cardiac arrhythmia, or decompensated cardiac insufficiency.
- Asthma, emphysema, chronic bronchitis, or chronic obstructive pulmonary disease (COPD) considered inappropriate for study participation by the investigator.
- Severe hepatic impairment (Child-Pugh Class C).
- Severe renal dysfunction requiring preoperative dialysis.
- Inability to provide valid informed consent due to cultural background, language barrier, or cognitive impairment.
- Refusal to sign the informed consent form.
- Other conditions deemed inappropriate for study participation by the investigator.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：The nasal spray group (Group D) ：Dexmedetomidine hydrochloride nasal spray 100μg
In the nasal spray group (Group D), the investigational product is dexmedetomidine hydrochloride nasal spray with a strength of 25 μg per spray.
Two sprays will be administered into each nostril, resulting in a total dexmedetomidine dose of 100 μg.
|
The nasal spray group (Group D) trial medication specification is dexmedetomidine hydrochloride nasal spray at 25μg per spray.
Two sprays are administered into each nostril, totalling 100μg of dexmedetomidine.
|
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プラセボコンパレーター：The control group (Group C)：Placebo nasal spray 100μg
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.
|
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of postoperative delirium (POD) within the first 3 days after surgery
時間枠：postoperative days 1 through 3
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Patients will be assessed twice daily using the 3-Minute Delirium Assessment Scale (3D-CAM) on postoperative days 1 through 3.
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postoperative days 1 through 3
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time from End of Surgery to Tracheal Extubation (Minutes)
時間枠：From the immediate end of surgery until successful tracheal extubation, assessed up to 2 hours after surgery completion (prior to discharge from the Post-Anesthesia Care Unit [PACU]).
|
The time interval, measured in minutes, between the surgeon's confirmed end of surgery (defined as completion of final wound closure) and complete removal of the tracheal tube from the patient's airway, documented via the official electronic anesthesia record.
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From the immediate end of surgery until successful tracheal extubation, assessed up to 2 hours after surgery completion (prior to discharge from the Post-Anesthesia Care Unit [PACU]).
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Duration of Post-Anesthesia Care Unit (PACU) Stay (Minutes)
時間枠：From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.
|
The time interval, measured in minutes, between two standardized, timestamped endpoints: 1. Start point: The time of patient admission to the PACU, defined as the time when the patient is transferred into the PACU and connected to standard vital sign monitoring; 2. End point: The time of patient discharge from the PACU, defined as the time when the patient physically exits the PACU after meeting institutional discharge criteria.
Data is prospectively documented in the official electronic anesthesia/PACU medical record.
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From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.
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Incidence of adverse events
時間枠：From administration of the investigational product up to 7 days postoperatively.
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Incidence of adverse events following administration of the investigational product.
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From administration of the investigational product up to 7 days postoperatively.
|
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Subjective sleep quality
時間枠：postoperative days 1 through 3
|
Patient-reported subjective sleep quality, assessed daily using the 11-point Numerical Rating Scale (NRS, 0 = best sleep, 10 = worst sleep) on postoperative days 1-3.
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postoperative days 1 through 3
|
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NRS pain score
時間枠：Before discharge from the PACU and on postoperative days 1 through 3.
|
Pain score will be assessed using the Numerical Rating Scale (NRS) before discharge from the post-anesthesia care unit (PACU) and daily on postoperative days 1-3.
(0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain)
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Before discharge from the PACU and on postoperative days 1 through 3.
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The severity of postoperative delirium
時間枠：postoperative days 1 through 3
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Delirium severity will be assessed using the Memorial Delirium Assessment Scale (MDAS) in patients with positive delirium on postoperative days 1-3.
The MDAS consists of 10 items with a total score of 30; the severity of delirium is defined as the maximum MDAS score obtained during postoperative days 1-3.
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postoperative days 1 through 3
|
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Duration of delirium
時間枠：Time from delirium onset to resolution, assessed up to 7 days postoperatively.
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The period commencing from the day delirium was first assessed as positive until delirium was assessed as negative or the patient was discharged.
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Time from delirium onset to resolution, assessed up to 7 days postoperatively.
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Duration of Postoperative Hospital Stay (Days)
時間枠：From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.
|
Defined as the total number of calendar days from the day of index surgery to the day of hospital discharge.
Discharge is defined as the time when the patient is formally discharged and physically leaves the hospital facility, recorded in the electronic hospital medical record.
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From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年12月31日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年3月23日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年3月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- SPPH2025585
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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