A 2×2 Factorial Randomized Controlled Trial for ERCP

NCT07584902 | Not Yet Recruiting DMC

• 1 other identifier: ERCP for older patient
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biliary and Pancreatic Diseases; Endoscopic Retrograde Cholangiopancreatography (ERCP)

Outcome Measures

Primary Outcomes (2)

• 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 (14)

• Severe hypoxemia

  Perioperative

• Hypotension/hypertension requiring the use of vasopressors.

  Perioperative

• Body movement.

  Perioperative

• Coughing

  Perioperative

• Hiccup

  Perioperative

Study Arms (4)

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

Interventions

Anesthesia induction using propofol+sufentanil DRUG

Anesthesia induction using propofol+sufentanil

propofol + sufentanil

Anesthesia induction using propofol+esketamine DRUG

Anesthesia induction using propofol+esketamine

propofol + esketamine

Anesthesia induction using ciprofol+sufentanil DRUG

Anesthesia induction using ciprofol+sufentanil

ciprofol + sufentanil

Anesthesia induction using ciprofol+es-ketamine DRUG

Anesthesia induction using ciprofol+esketamine

ciprofol + esketamine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gang Chen: lead

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Xiaocui Lv

CONTACT

13567109477; 3412008@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: May 13, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL