A 2×2 Factorial Randomized Controlled Trial for ERCP

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

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 Overview

• Status: Not yet recruiting
• Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP); Biliary and Pancreatic Diseases
• Intervention / Treatment: Drug: Anesthesia induction using propofol+sufentanil; Drug: Anesthesia induction using propofol+esketamine; Drug: Anesthesia induction using ciprofol+sufentanil; Drug: Anesthesia induction using ciprofol+es-ketamine

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaocui Lv; Phone Number: 13567109477; Email: 3412008@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: propofol + sufentanil	Drug: Anesthesia induction using propofol+sufentanil; Anesthesia induction using propofol+sufentanil
Active Comparator: propofol + esketamine	Drug: Anesthesia induction using propofol+esketamine; Anesthesia induction using propofol+esketamine
Active Comparator: ciprofol + sufentanil	Drug: Anesthesia induction using ciprofol+sufentanil; Anesthesia induction using ciprofol+sufentanil
Experimental: ciprofol + esketamine	Drug: Anesthesia induction using ciprofol+es-ketamine; Anesthesia induction using ciprofol+esketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	Perioperative
Body movement.	During ERCP, the patient's body movement affected the surgical procedure	Perioperative
Coughing	During ERCP, the patient experienced coughing, which affected the surgical progress	Perioperative
Hiccup	During ERCP, the patient experienced Hiccup, which affected the surgical progress。	Perioperative
Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation	Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation	Perioperative
Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute).	Tachycardia (HR>100 beats/minute) or bradycardia (HR<50 beats/minute).	Perioperative
The dosage of remifentanil used.	The dosage of remifentanil used.	Perioperative
Recovery room time	The time from removing the endoscope to reaching an Aldrete score of 10 in the endoscopic recovery room and leaving the room.	Perioperative
Postoperative recovery quality (QoR-15 scale score)	Use the QOR15 rating scale for scoring, with higher scores indicating better recovery quality	The first day after surgery.
Postoperative nausea and vomiting.	the incidence of postoperative nausea and vomiting.	postoperative
Patient satisfaction	A 10 point visual analog scale was used to evaluate patient satisfaction with sedation types. Among them, 1 represents the worst experience, and 10 represents the best experience. The first day after ERCP, patients record their experience by checking the corresponding score on this scale.	postoperative day 1
Endoscope satisfaction	A 10 point visual analog scale was used to evaluate endoscope satisfaction with sedation types. Among them, 1 represents the worst experience, and 10 represents the best experience.	postoperative Day 1
Hospitalization duration	The total length of hospital stay for the patient in this treatment	after discharge

Collaborators and Investigators

• Sponsor: Gang Chen

Study record dates

Study Major Dates

• Study Start (Estimated): April 27, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: ERCP for older patient

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No