Biliary and Pancreatic DiseasesNCT07584902
A 2×2 Factorial Randomized Controlled Trial for ERCP
A study testing Anesthesia induction using propofol+sufentanil, Anesthesia induction using propofol+esketamine and Anesthesia induction using ciprofol+sufentanil in people with Biliary and Pancreatic Diseases and Endoscopic Retrograde Cholangiopancreatography (ERCP), run by Gang Chen.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Biliary and Pancreatic Diseases, Endoscopic Retrograde Cholangiopancreatography (ERCP)
- What is being tested?
- Anesthesia induction using propofol+sufentanil, Anesthesia induction using propofol+esketamine and Anesthesia induction using ciprofol+sufentanil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Anesthesia induction using propofol+sufentanil, Anesthesia induction using propofol+esketamine, Anesthesia induction using ciprofol+sufentanil, Anesthesia induction using ciprofol+es-ketamine
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia induction using propofol+sufentanilDrug
Anesthesia induction using propofol+sufentanil
Anesthesia induction using propofol+esketamineDrug
Anesthesia induction using propofol+esketamine
Anesthesia induction using ciprofol+sufentanilDrug
Anesthesia induction using ciprofol+sufentanil
Anesthesia induction using ciprofol+es-ketamineDrug
Anesthesia induction using ciprofol+esketamine
| Study group | Role | What they receive |
|---|---|---|
| propofol + sufentanil | Sham comparator | Not described Receives: Drug: Anesthesia induction using propofol+sufentanil |
| propofol + esketamine | Active comparator | Not described Receives: Drug: Anesthesia induction using propofol+esketamine |
| ciprofol + sufentanil | Active comparator | Not described Receives: Drug: Anesthesia induction using ciprofol+sufentanil |
| ciprofol + esketamine | Experimental | Not described Receives: Drug: Anesthesia induction using ciprofol+es-ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoxemia
SpO2≤92%
Measured: perioperative
Hypotension
blood pressure drop exceeding 20% of the baseline value, with mean arterial pressure ≤65 mmHg or systolic blood pressure ≤90 mmHg
Measured: Perioperative
Secondary outcomes (14)
Severe hypoxemia
75% ≤ SpO2<90%>60 s, SpO2<75%.
Measured: Perioperative
Hypotension/hypertension requiring the use of vasopressors.
Hypotension/hypertension requiring the use of vasopressors.
Measured: Perioperative
Body movement.
During ERCP, the patient's body movement affected the surgical procedure
Measured: Perioperative
Coughing
During ERCP, the patient experienced coughing, which affected the surgical progress
Measured: Perioperative
Hiccup
During ERCP, the patient experienced Hiccup, which affected the surgical progress。
Measured: 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
Measured: Perioperative
Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute).
Tachycardia (HR>100 beats/minute) or bradycardia (HR<50 beats/minute).
Measured: Perioperative
The dosage of remifentanil used.
The dosage of remifentanil used.
Measured: 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.
Measured: Perioperative
Postoperative recovery quality (QoR-15 scale score)
Use the QOR15 rating scale for scoring, with higher scores indicating better recovery quality
Measured: The first day after surgery.
Postoperative nausea and vomiting.
the incidence of postoperative nausea and vomiting.
Measured: 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.
Measured: 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.
Measured: postoperative Day 1
Hospitalization duration
The total length of hospital stay for the patient in this treatment
Measured: after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start27 Apr 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary and Pancreatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Chen, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584902
- Sponsor's protocol ID
- ERCP for older patient
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07584902
- Acronym / sponsor ID
- ERCP for older patient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Gang ChenUniversity, hospital or other
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia induction using propofol+sufentanilAnesthesia induction using propofol+sufentanil | Drug | propofol + sufentanil |
| Anesthesia induction using propofol+esketamineAnesthesia induction using propofol+esketamine | Drug | propofol + esketamine |
| Anesthesia induction using ciprofol+sufentanilAnesthesia induction using ciprofol+sufentanil | Drug | ciprofol + sufentanil |
| Anesthesia induction using ciprofol+es-ketamineAnesthesia induction using ciprofol+esketamine | Drug | ciprofol + esketamine |
Primary outcome
hypoxemia
Time frame: perioperative
SpO2≤92%
Hypotension
Time frame: Perioperative
blood pressure drop exceeding 20% of the baseline value, with mean arterial pressure ≤65 mmHg or systolic blood pressure ≤90 mmHg
14 secondary outcomes
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
Endoscope satisfaction
Time frame: postoperative Day 1
Hospitalization duration
Time frame: after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes
Related trials for Biliary and Pancreatic Diseases
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 1/2
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
EUS Procedures Using RIVOS™ EUS Access Device
Pancreatic Fluid Collections, Biliary Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia induction using propofol+sufentanil, Anesthesia induction using propofol+esketamine and Anesthesia induction using ciprofol+sufentanil in people with Biliary and Pancreatic Diseases and Endoscopic Retrograde Cholangiopancreatography (ERCP), run by Gang Chen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaocui Lv (13567109477, 3412008@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypoxemia (time frame: perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.