NCT07584902尚未招募不适用
Effects of Propofol Versus Ciprofol and Sufentanil Versus Es-ketamine on Intraoperative Desaturation and Hypotension in Elderly Patients Undergoing ERCP: A 2×2 Factorial Randomized Controlled Trial
Gang Chen0 个研究点目标入组 236 人开始时间: 2026年4月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 236
研究概览
简要总结
To investigate the effects of propofol vs. cyclopropofol and sufentanil vs. esketamine on intraoperative hypoxemia and hypotension in elderly patients undergoing ERCP, as well as the interaction between these two factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years old.
- •ASA II-III level.
- •BMI<30kg/m
- •Patients who require elective therapeutic ERCP.
- •Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of capacity, their guardian needs to act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.
排除标准
- •Previous anatomical changes in the gastrointestinal tract, delayed gastric emptying, and gastric outlet obstruction.
- •Coagulation dysfunction or tendency towards nosebleeds.
- •Combined severe heart disease (coronary heart disease, myocardial infarction, congestive heart failure, left ventricular ejection fraction<40%, tachyarrhythmia)
- •Have a history of allergies to relevant anesthetic drugs in the past.
- •Severe pulmonary diseases (severe asthma attacks, respiratory failure, severe chronic obstructive pulmonary disease, severe interstitial lung disease, large pleural effusion, severe pulmonary arterial hypertension, etc.).
- •Existing upper respiratory tract infection (within one week).
- •Uncontrolled severe hypertension.
- •Patients with increased intracranial pressure; Cerebral hemorrhage, intracranial space occupying lesions, acute phase of traumatic brain injury.
- •Glaucoma and significant increase in intraocular pressure.
- •Untreated or inadequately treated patients with hyperthyroidism.
- •Serious liver and kidney diseases.
- •Known neurological and psychiatric disorders (Parkinson's disease, epilepsy, or schizophrenia).
- •Difficult airway: The anesthesiologist assessed the presence of difficult airway before surgery.
- •Vulnerable groups other than the elderly/illiterate, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, etc.
研究者
Gang Chen
Chief Physician
Sir Run Run Shaw Hospital
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