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A 2×2 Factorial Randomized Controlled Trial for ERCP

ConditionsBiliary and Pancreatic DiseasesEndoscopic Retrograde Cholangiopancreatography (ERCP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorGang Chen

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 60 years old.

ASA II-III level.

BMI<30kg/m2.

Patients who require elective therapeutic ERCP.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anesthesia induction using propofol+sufentanil

    Drug

    Anesthesia induction using propofol+sufentanil

  • Anesthesia induction using propofol+esketamine

    Drug

    Anesthesia induction using propofol+esketamine

  • Anesthesia induction using ciprofol+sufentanil

    Drug

    Anesthesia induction using ciprofol+sufentanil

  • Anesthesia induction using ciprofol+es-ketamine

    Drug

    Anesthesia induction using ciprofol+esketamine

Treatment groups

236 Participants
are divided into 4 treatment groups
Group A: propofol + sufentanilSham comparator 1 intervention
Group B: propofol + esketamineActive comparator 1 intervention
Group C: ciprofol + sufentanilActive comparator 1 intervention
Group D: ciprofol + esketamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

hypoxemia

SpO2≤92%

Time frame
perioperative
2

Hypotension

blood pressure drop exceeding 20% of the baseline value, with mean arterial pressure ≤65 mmHg or systolic blood pressure ≤90 mmHg

Time frame
Perioperative

Secondary outcomes

1

Severe hypoxemia

75% ≤ SpO2\<90%\>60 s, SpO2\<75%.

Time frame
Perioperative
2

Hypotension/hypertension requiring the use of vasopressors.

Hypotension/hypertension requiring the use of vasopressors.

Time frame
Perioperative
3

Body movement.

During ERCP, the patient's body movement affected the surgical procedure

Time frame
Perioperative
4

Coughing

During ERCP, the patient experienced coughing, which affected the surgical progress

Time frame
Perioperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gang Chen

Lead sponsor

Sir Run Run Shaw Hospital

Sponsor institution

Source ClinicalTrials.gov

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