Anesthesia; Adverse Effect, Biliary Tract Diseases
Conditions
Keywords
Ciprofol, Propofol, Intravenous Anesthesia, Elective Endoscopic Retrograde Cholangiopancreatography, Hypoxia
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.
Interventions
DRUGPropofol
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.
DRUGCiprofol
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.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| patient satisfaction score | 5 minutes | Patients' satisfaction score is measured by patient recovery satisfaction score, from -33 the worst to 33 the best. |
| 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 |
| 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 |
| the incidence of postoperative adverse bile excretion | 30 days after operation | patients with symptoms or signs of postoperative adverse bile excretion |
| the incidence of severe postoperative hypoxia | 30 days after operation | patients with symptoms or signs of severe postoperative hypoxia |
| the incidence of severe postoperative circulatory disfunction | 30 days after operation | patients with symptoms or signs of severe postoperative circulatory disfunction |
| the incidence of mortality within 30 days after operation | 30 days after operation | mortality within 30 days after operation |
| length of stay | 2-7days | length of stay in hospital |
Countries
China
Contacts
Primary ContactPeiying Li, Doctor
Outcome results
None listed