Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP

N/ANot Yet RecruitingNCT06015074

RenJi Hospital136 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

136

Conditions

Anesthesia; Adverse Effect Biliary Tract Diseases

Interventions

PropofolDRUG

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.

CiprofolDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine,

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

the incidence of hypoxia

the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) \< 90%

Time frame: from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours

Secondary Outcomes

the incidence of hypercapnia

arterial carbon dioxide partial pressure（PaCO2）\>50mmHg

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Central Contacts

Peiying Li, Doctor

CONTACT

15800616866 peiyingli.md@gmail.com

Data from ClinicalTrials.gov

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