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NCT Number: NCT07584902

A 2×2 Factorial Randomized Controlled Trial for ERCP

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. hypoxemia

    Time frame: perioperative

    SpO2≤92%

  2. 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

Secondary outcomes

  1. Severe hypoxemia

    Time frame: Perioperative

    75% ≤ SpO2<90%>60 s, SpO2<75%.

  2. Hypotension/hypertension requiring the use of vasopressors.

    Time frame: Perioperative

    Hypotension/hypertension requiring the use of vasopressors.

  3. Body movement.

    Time frame: Perioperative

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

  4. Coughing

    Time frame: Perioperative

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

  5. Hiccup

    Time frame: Perioperative

    During ERCP, the patient experienced Hiccup, which affected the surgical progress。

  6. Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation

    Time frame: Perioperative

    Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation

  7. Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute).

    Time frame: Perioperative

    Tachycardia (HR>100 beats/minute) or bradycardia (HR<50 beats/minute).

  8. The dosage of remifentanil used.

    Time frame: Perioperative

    The dosage of remifentanil used.

  9. Recovery room time

    Time frame: Perioperative

    The time from removing the endoscope to reaching an Aldrete score of 10 in the endoscopic recovery room and leaving the room.

  10. Postoperative recovery quality (QoR-15 scale score)

    Time frame: The first day after surgery.

    Use the QOR15 rating scale for scoring, with higher scores indicating better recovery quality

  11. Postoperative nausea and vomiting.

    Time frame: postoperative

    the incidence of postoperative nausea and vomiting.

  12. Patient satisfaction

    Time frame: postoperative day 1

    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.

  13. Endoscope satisfaction

    Time frame: postoperative Day 1

    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.

  14. Hospitalization duration

    Time frame: after discharge

    The total length of hospital stay for the patient in this treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaocui Lv

CONTACT

[email protected]

13567109477

Sponsors and collaborators

Lead sponsor

Gang Chen

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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