NCT07584902Not yet recruitingNot Applicable
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 sites236 target enrollmentStarted: April 27, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 236
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
Gang Chen
Chief Physician
Sir Run Run Shaw Hospital
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