Not Yet RecruitingN/Aketamine
A 2×2 Factorial Randomized Controlled Trial for ERCP
Sponsored by Gang Chen
NCT ID
NCT07584902
Target Enrollment
236 participants
Start Date
2026-04-27
Est. Completion
2026-10-31
About This Study
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.
Conditions Studied
Interventions
- •Anesthesia induction using propofol+sufentanil
- •Anesthesia induction using propofol+esketamine
- •Anesthesia induction using ciprofol+sufentanil
- •Anesthesia induction using ciprofol+es-ketamine
Eligibility
Age:60 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Age ≥ 60 years old. * ASA II-III level. * BMI\<30kg/m2. * 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.