Not yet recruiting NCT07584902
A 2×2 Factorial Randomized Controlled Trial for ERCP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anesthesia induction using propofol+sufentanil, Anesthesia induction using propofol+esketamine, Anesthesia induction using ciprofol+sufentanil, Anesthesia induction using ciprofol+es-ketamine.
- Who it may be relevant to
- Registry conditions: Biliary and Pancreatic Diseases, Endoscopic Retrograde Cholangiopancreatography (ERCP). Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Anesthesia induction using propofol+sufentanil
Anesthesia induction using propofol+sufentanil - Drug Anesthesia induction using propofol+esketamine
Anesthesia induction using propofol+esketamine - Drug Anesthesia induction using ciprofol+sufentanil
Anesthesia induction using ciprofol+sufentanil - Drug Anesthesia induction using ciprofol+es-ketamine
Anesthesia induction using ciprofol+esketamine
Primary outcome measures
- hypoxemia [Time frame: perioperative]
- Hypotension [Time frame: Perioperative]
Secondary outcome measures (12)
- Severe hypoxemia [Time frame: Perioperative]
- Hypotension/hypertension requiring the use of vasopressors. [Time frame: Perioperative]
- Body movement. [Time frame: Perioperative]
- Coughing [Time frame: Perioperative]
- Hiccup [Time frame: Perioperative]
- Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation [Time frame: Perioperative]
- Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute). [Time frame: Perioperative]
- The dosage of remifentanil used. [Time frame: Perioperative]
- Recovery room time [Time frame: Perioperative]
- Postoperative recovery quality (QoR-15 scale score) [Time frame: The first day after surgery.]
- Postoperative nausea and vomiting. [Time frame: postoperative]
- Patient satisfaction [Time frame: postoperative day 1]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07584902 · ERCP for older patient