Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Thoracoscopic Lung Resection Patients
2026년 5월 6일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
264
단계
- 4단계
연락처 및 위치
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연구 연락처
- 이름: Peng LI
- 전화번호: +86 13668169590
- 이메일: lipengmazui@163.com
연구 연락처 백업
- 이름: Shaomao Jia
- 전화번호: +86 13419213559
- 이메일: 670979499@qq.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
위약 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The incidence of postoperative delirium (POD) within the first 3 days after surgery
기간: postoperative days 1 through 3
|
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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time from End of Surgery to Tracheal Extubation (Minutes)
기간: 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]).
|
|
Duration of Post-Anesthesia Care Unit (PACU) Stay (Minutes)
기간: 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
기간: 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.
|
|
Subjective sleep quality
기간: 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.
|
postoperative days 1 through 3
|
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NRS pain score
기간: Before discharge from the PACU and on postoperative days 1 through 3.
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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
기간: postoperative days 1 through 3
|
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
|
|
Duration of delirium
기간: 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)
기간: From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.
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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.
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연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2026년 12월 31일
연구 완료 (추정된)
2026년 12월 31일
연구 등록 날짜
최초 제출
2026년 3월 23일
QC 기준을 충족하는 최초 제출
2026년 5월 6일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 6일
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2026년 3월 1일
추가 정보
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키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- SPPH2025585
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