Clinical trial NCT06015074: Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP
Official title: Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia; Adverse Effect
Biliary Tract Diseases
Keywords: Ciprofol
Propofol
Intravenous Anesthesia
Elective Endoscopic Retrograde Cholangiopancreatography
Hypoxia
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Intravenous anesthesia has been widely used in endoscopic retrograde cholangiopancreatography (ERCP). In the past decade, many practices have been carried out under the propofol-based monitored anesthesia care without endotracheal intubation in patients undergoing ERCP.

Ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of propofol. Ciprofol seems a promising anesthetic agent for intravenous anesthesia but the evidence supported its application in ERCP is still limited.

Detailed description: This is a prospective, randomized, double-blind trial comparing the incidence of hypoxia in the propofol versus ciprofol intravenous Anesthesia. A total 136 patients will be recruited and randomly assigned to either the propofol or the ciprofol group. The primary outcome is the proportion of patients experiencing hypoxia. The secondary outcomes include: the incidence of hypotension in perioperative period; the incidence of conversion from intravenous anesthesia to general anesthesia; sedation-related procedure interruption; carbon dioxide( CO2) accumulation during operation; Patients' satisfaction with anesthesia and postoperative recovery / VAS score / incidence of nausea and vomiting; the incidence of intraoperative and postoperative adverse events, such as adverse excretion, severe hypoxemia, severe circulatory dysfunction; length of stay and mortality within 30 days after operation.

Eligibility criteria: Inclusion Criteria:

* patients undergoing ERCP, ASA I-III
* normal renal function
* BMI ≥ 18kg/m 2 and ≤ 30kg/m 2

Exclusion Criteria:

* Previous serious cerebrovascular accidents and other neurological diseases
* mental diseases, long-term use of drugs that affect the function of the central nervous system, benzodiazepines or opioids
* history of anesthetic allergy
* preoperative hypotension or preoperative SpO2 \< 90%, or chronic respiratory failure
* patients suspected of having difficult airways
* screening for drug addiction and alcohol abuse within the first 3 months (\> = 6standarddrinks/day)
* patients diagnosed with severe cardiopulmonary disease, or respiratory or respiratory diseases such as sleep apnea syndrome;
* bradycardia or atrioventricular block.
* participate in other clinical trials within 4 weeks;
* cognitive or communication abnormalities determined by the researchers;
* emergent and critical conditions during the operation;
* other conditions that the researchers believe are not suitable to participate in the study.

Primary outcomes:
measure: the incidence of hypoxia
timeFrame: from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours
Secondary outcomes:
measure: the incidence of hypercapnia
timeFrame: 5 minutes each time（base line, 10 minutes after beginning of surgery, completion of surgery, 10 minutes after awakening）
measure: the incidence of hypotension
timeFrame: from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours
measure: sedation-related procedure interruption
timeFrame: from the induction of anesthesia to completion of ERCP, about 30 minutes
measure: conversion from intravenous anesthesia to general anesthesia
timeFrame: from the induction of anesthesia to completion of ERCP, about 30 minutes
measure: patient satisfaction score
timeFrame: 5 minutes
measure: visual analog scale (VAS) scores
timeFrame: 30 seconds
measure: length of stay
timeFrame: 2-7days
measure: the incidence of postoperative adverse bile excretion
timeFrame: 30 days after operation
measure: the incidence of severe postoperative hypoxia
timeFrame: 30 days after operation
measure: the incidence of severe postoperative circulatory disfunction
timeFrame: 30 days after operation
measure: the incidence of mortality within 30 days after operation
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine,
state: Shanghai
Study officials:
affiliation: Clinial Research Center, Renji Hospital
name: Peiying Li, Doctor
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology, Renji Hospital
name: Yu Weifeng, Doctor
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, Renji Hospital
name: Zheng Li, Master
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology, Renji Hospital
name: Yanhua Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Renji Hospital
name: Yifeng Qu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Renji Hospital
name: Kun Luo, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Operating Room，Renji Hospital
name: Guangyan Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Renji Hospital
name: Teng Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Renji Hospital
name: Huichen Zhu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinial Research Center, Renji Hospital
name: Jing Gao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.
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citation: Liu Y, Chen C, Liu N, Tong L, Nie Y, Wu J, Liu X, Gao W, Tang L, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol. Adv Ther. 2021 Oct;38(10):5412-5423. doi: 10.1007/s12325-021-01877-6. Epub 2021 Aug 21.