Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP

Study Overview
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Brief Summary
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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
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This is a prospective, randomized, double-blind trial comparing the incidence of hypoxia in the propofol versus ciprofol intravenous Anesthesia. A total 124 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; 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.

Official Title
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Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial.

Conditions
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Anesthesia; Adverse Effect, Biliary Tract Diseases

Intervention / Treatment
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* Drug: Propofol
* Drug: Ciprofol


Participation Criteria
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Eligibility Criteria
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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 SP02 < 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol group<br>patients in Propofol group receive sufentanil+ propofol | Drug: Propofol<br>* patients in Propofol group receive sufentanil(0.1ug/kg)+ propofol (1.5-2mg/kg) for anesthesia induction, and continuous infusion of propofol 5mg/kg/h for anesthesia maintain.<br>* Other names: Fresenius Kabi，China;|
| Experimental: Ciprofol group<br>patients in Ciprofol group receive sufentanil+ ciprofol | Drug: Ciprofol<br>* patients in Ciprofol group receive sufentanil(0.1ug/kg)+ ciprofol(0.4-0.5mg/kg) for anesthesia induction, and continuous infusion of ciprofol 0.8mg/kg/h for anesthesia maintain.<br>* Other names: Haisike，China;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of hypoxia | the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90% | from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of hypercapnia | arterial carbon dioxide partial pressure（PaCO2）>50mmHg | 5 minutes each time（base line, 10 minutes after beginning of surgery, completion of surgery, 10 minutes after awakening） | 
| the incidence of hypotension | invasive systolic pressure<90mmHg | from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours | 
| sedation-related procedure interruption | the incidence of interruption of procedure due to intolerance or severe adverse events | from the induction of anesthesia to completion of ERCP, about 30 minutes | 
| conversion from intravenous anesthesia to general anesthesia | the incidence of conversion from intravenous anesthesia to general anesthesia due to intolerance or severe adverse events | from the induction of anesthesia to completion of ERCP, about 30 minutes | 
| patient satisfaction score | Patients' satisfaction score is measured by patient recovery satisfaction score, from -33 the worst to 33 the best. | 5 minutes | 
| visual analog scale (VAS) scores | perioperative pain is measured by visual analog scale (VAS) scores，from painless score 0 to the imagined most severe pain score 10 | 30 seconds | 
| length of stay | length of stay in hospital | 2-7days | 
| the incidence of postoperative adverse bile excretion | patients with symptoms or signs of postoperative adverse bile excretion | 30 days after operation | 
| the incidence of severe postoperative hypoxia | patients with symptoms or signs of severe postoperative hypoxia | 30 days after operation | 
| the incidence of severe postoperative circulatory disfunction | patients with symptoms or signs of severe postoperative circulatory disfunction | 30 days after operation | 
| the incidence of mortality within 30 days after operation | mortality within 30 days after operation | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ciprofol, Propofol, Intravenous Anesthesia, Elective Endoscopic Retrograde Cholangiopancreatography, Hypoxia