Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP

Sponsor

RenJi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06015074

Collaborator

(none)

124

Enrollment

Location

Arms

Anticipated Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Adverse Effect Biliary Tract Diseases	Drug: Propofol Drug: Ciprofol	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Propofol group patients in Propofol group receive sufentanil+ propofol	Drug: Propofol 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. Other Names: Fresenius Kabi，China
Experimental: Ciprofol group patients in Ciprofol group receive sufentanil+ ciprofol	Drug: Ciprofol 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. Other Names: Haisike，China

Arm

Intervention/Treatment

Active Comparator: Propofol group

patients in Propofol group receive sufentanil+ propofol

Drug: Propofol

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.

Other Names:

Fresenius Kabi，China

Experimental: Ciprofol group

patients in Ciprofol group receive sufentanil+ ciprofol

Drug: Ciprofol

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.

Other Names:

Haisike，China

Outcome Measures

Primary Outcome Measures

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

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 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
length of stay [2-7days]
length of stay in hospital
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital, Shanghai Jiao Tong University School of Medicine,	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

RenJi Hospital

Investigators

Study Director: Peiying Li, Doctor, Clinial Research Center, Renji Hospital
Study Chair: Yu Weifeng, Doctor, Department of Anesthesiology, Renji Hospital
Study Director: Zheng Li, Master, Department of Anesthesiology, Renji Hospital
Principal Investigator: Yanhua Zhao, Doctor, Department of Anesthesiology, Renji Hospital
Principal Investigator: Yifeng Qu, Master, Department of Anesthesiology, Renji Hospital
Principal Investigator: Kun Luo, Master, Department of Anesthesiology, Renji Hospital
Principal Investigator: Guangyan Wang, Operating Room，Renji Hospital
Principal Investigator: Teng Wang, Department of Anesthesiology, Renji Hospital
Principal Investigator: Huichen Zhu, Master, Department of Anesthesiology, Renji Hospital
Principal Investigator: Jing Gao, Doctor, Clinial Research Center, Renji Hospital