Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP
- Conditions
- Biliary Tract DiseasesAnesthesia; Adverse Effect
- Interventions
- Registration Number
- NCT06015074
- Lead Sponsor
- RenJi Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 136
- patients undergoing ERCP, ASA I-III
- normal renal function
- BMI ≥ 18kg/m 2 and ≤ 30kg/m 2
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol group Propofol patients in Propofol group receive sufentanil+ propofol Ciprofol group Ciprofol patients in Ciprofol group receive sufentanil+ ciprofol
- Primary Outcome Measures
Name Time Method the incidence of hypoxia from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) \< 90%
- Secondary Outcome Measures
Name Time Method sedation-related procedure interruption from the induction of anesthesia to completion of ERCP, about 30 minutes the incidence of interruption of procedure due to intolerance or severe adverse events
the incidence of severe postoperative hypoxia 30 days after operation patients with symptoms or signs of severe postoperative hypoxia
patient satisfaction score 5 minutes Patients' satisfaction score is measured by patient recovery satisfaction score, from -33 the worst to 33 the best.
the incidence of postoperative adverse bile excretion 30 days after operation patients with symptoms or signs of postoperative adverse bile excretion
the incidence of mortality within 30 days after operation 30 days after operation mortality within 30 days after operation
the incidence of hypotension from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours invasive systolic pressure\<90mmHg
conversion from intravenous anesthesia to general anesthesia from the induction of anesthesia to completion of ERCP, about 30 minutes the incidence of conversion from intravenous anesthesia to general anesthesia due to intolerance or severe adverse events
the incidence of severe postoperative circulatory disfunction 30 days after operation patients with symptoms or signs of severe postoperative circulatory disfunction
the incidence of hypercapnia 5 minutes each time（base line, 10 minutes after beginning of surgery, completion of surgery, 10 minutes after awakening） arterial carbon dioxide partial pressure（PaCO2）\>50mmHg
visual analog scale (VAS) scores 30 seconds perioperative pain is measured by visual analog scale (VAS) scores，from painless score 0 to the imagined most severe pain score 10
length of stay 2-7days length of stay in hospital
Trial Locations
- Locations (1)
Renji Hospital, Shanghai Jiao Tong University School of Medicine,
🇨🇳Shanghai, Shanghai, China