Back to resultsCiprofol vs Propofol for Reducing Hypoxia Incidence in ERCP
Primary Purpose
Anesthesia; Adverse Effect, Biliary Tract Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Propofol
Ciprofol
Sponsored by
About this trial
This is an interventional other trial for Anesthesia; Adverse Effect focused on measuring Ciprofol, Propofol, Intravenous Anesthesia, Elective Endoscopic Retrograde Cholangiopancreatography, Hypoxia
Eligibility Criteria
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.
Sites / Locations
- Renji Hospital, Shanghai Jiao Tong University School of Medicine,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Propofol group
Ciprofol group
Arm Description
patients in Propofol group receive sufentanil+ propofol
patients in Ciprofol group receive sufentanil+ ciprofol
Outcomes
Primary Outcome Measures
the incidence of hypoxia
the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90%
Secondary Outcome Measures
the incidence of hypercapnia
arterial carbon dioxide partial pressure（PaCO2）>50mmHg
the incidence of hypotension
invasive systolic pressure<90mmHg
sedation-related procedure interruption
the incidence of interruption of procedure due to intolerance or severe adverse events
conversion from intravenous anesthesia to general anesthesia
the incidence of conversion from intravenous anesthesia to general anesthesia due to intolerance or severe adverse events
patient satisfaction score
Patients' satisfaction score is measured by patient recovery satisfaction score, from -33 the worst to 33 the best.
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
length of stay
length of stay in hospital
the incidence of postoperative adverse bile excretion
patients with symptoms or signs of postoperative adverse bile excretion
the incidence of severe postoperative hypoxia
patients with symptoms or signs of severe postoperative hypoxia
the incidence of severe postoperative circulatory disfunction
patients with symptoms or signs of severe postoperative circulatory disfunction
the incidence of mortality within 30 days after operation
mortality within 30 days after operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06015074
Brief Title
Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP
Official Title
Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Adverse Effect, Biliary Tract Diseases
Keywords
Ciprofol, Propofol, Intravenous Anesthesia, Elective Endoscopic Retrograde Cholangiopancreatography, Hypoxia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol group
Arm Type
Active Comparator
Arm Description
patients in Propofol group receive sufentanil+ propofol
Arm Title
Ciprofol group
Arm Type
Experimental
Arm Description
patients in Ciprofol group receive sufentanil+ ciprofol
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Fresenius Kabi，China
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ciprofol
Other Intervention Name(s)
Haisike，China
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of hypoxia
Description
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 Outcome Measure Information:
Title
the incidence of hypercapnia
Description
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）
Title
the incidence of hypotension
Description
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
Title
sedation-related procedure interruption
Description
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
Title
conversion from intravenous anesthesia to general anesthesia
Description
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
Title
patient satisfaction score
Description
Patients' satisfaction score is measured by patient recovery satisfaction score, from -33 the worst to 33 the best.
Time Frame
5 minutes
Title
visual analog scale (VAS) scores
Description
perioperative pain is measured by visual analog scale (VAS) scores，from painless score 0 to the imagined most severe pain score 10
Time Frame
30 seconds
Title
length of stay
Description
length of stay in hospital
Time Frame
2-7days
Title
the incidence of postoperative adverse bile excretion
Description
patients with symptoms or signs of postoperative adverse bile excretion
Time Frame
30 days after operation
Title
the incidence of severe postoperative hypoxia
Description
patients with symptoms or signs of severe postoperative hypoxia
Time Frame
30 days after operation
Title
the incidence of severe postoperative circulatory disfunction
Description
patients with symptoms or signs of severe postoperative circulatory disfunction
Time Frame
30 days after operation
Title
the incidence of mortality within 30 days after operation
Description
mortality within 30 days after operation
Time Frame
30 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peiying Li, Doctor
Phone
15800616866
Email
peiyingli.md@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peiying Li, Doctor
Organizational Affiliation
Clinial Research Center, Renji Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yu Weifeng, Doctor
Organizational Affiliation
Department of Anesthesiology, Renji Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zheng Li, Master
Organizational Affiliation
Department of Anesthesiology, Renji Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yanhua Zhao, Doctor
Organizational Affiliation
Department of Anesthesiology, Renji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yifeng Qu, Master
Organizational Affiliation
Department of Anesthesiology, Renji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kun Luo, Master
Organizational Affiliation
Department of Anesthesiology, Renji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guangyan Wang
Organizational Affiliation
Operating Room，Renji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teng Wang
Organizational Affiliation
Department of Anesthesiology, Renji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huichen Zhu, Master
Organizational Affiliation
Department of Anesthesiology, Renji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Gao, Doctor
Organizational Affiliation
Clinial Research Center, Renji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital, Shanghai Jiao Tong University School of Medicine,
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiying Li, Doctor
Phone
+8615800616866
Email
peiyingli.md@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP
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