A 2×2 Factorial Randomized Controlled Trial for ERCP | NCT07584902

NCT07584902

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
propofol + sufentanil	Sham Comparator	Drug: Anesthesia induction using propofol+sufentanil
propofol + esketamine	Active Comparator	Drug: Anesthesia induction using propofol+esketamine
ciprofol + sufentanil	Active Comparator	Drug: Anesthesia induction using ciprofol+sufentanil
ciprofol + esketamine	Experimental	Drug: Anesthesia induction using ciprofol+es-ketamine

Name	Type	Description	Arm Group Labels	Other Names
Anesthesia induction using propofol+sufentanil	Drug	Anesthesia induction using propofol+sufentanil	propofol + sufentanil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hypoxemia	SpO2≤92%	perioperative
Hypotension	blood pressure drop exceeding 20% of the baseline value, with mean arterial pressure ≤65 mmHg or systolic blood pressure ≤90 mmHg	Perioperative

Secondary Outcomes

Measure	Description	Time Frame
Severe hypoxemia	75% ≤ SpO2<90%>60 s, SpO2<75%.	Perioperative
Hypotension/hypertension requiring the use of vasopressors.	Hypotension/hypertension requiring the use of vasopressors.

Eligibility Module

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.