Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biliary Tract Diseases; Anesthesia; Adverse Effect
• Intervention / Treatment: Drug: Propofol; Drug: Ciprofol

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.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peiying Li, Doctor; Phone Number: 15800616866; Email: peiyingli.md@gmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, Shanghai Jiao Tong University School of Medicine,
      • Contact: Peiying Li, Doctor; Phone Number: +8615800616866; Email: peiyingli.md@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of hypoxia	the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90%	from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of hypercapnia	arterial carbon dioxide partial pressure（PaCO2）>50mmHg	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	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	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	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.	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	30 seconds
length of stay	length of stay in hospital	2-7days
the incidence of postoperative adverse bile excretion	patients with symptoms or signs of postoperative adverse bile excretion	30 days after operation
the incidence of severe postoperative hypoxia	patients with symptoms or signs of severe postoperative hypoxia	30 days after operation
the incidence of severe postoperative circulatory disfunction	patients with symptoms or signs of severe postoperative circulatory disfunction	30 days after operation
the incidence of mortality within 30 days after operation	mortality within 30 days after operation	30 days after operation

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Vargo JJ, Zuccaro G Jr, Dumot JA, Shermock KM, Morrow JB, Conwell DL, Trolli PA, Maurer WG. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002 Jul;123(1):8-16. doi: 10.1053/gast.2002.34232.
• Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
• Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.
• Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.
• Paspatis GA, Manolaraki MM, Vardas E, Theodoropoulou A, Chlouverakis G. Deep sedation for endoscopic retrograde cholangiopancreatography: intravenous propofol alone versus intravenous propofol with oral midazolam premedication. Endoscopy. 2008 Apr;40(4):308-13. doi: 10.1055/s-2007-995346. Epub 2007 Dec 5.
• Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-42. doi: 10.1016/j.cgh.2009.07.008. Epub 2009 Jul 14.
• Alzanbagi AB, Jilani TL, Qureshi LA, Ibrahim IM, Tashkandi AMS, Elshrief EEA, Khan MS, Abdelhalim MAH, Zahrani SA, Mohamed WMK, Nageeb AM, Abbushi B, Shariff MK. Randomized trial comparing general anesthesia with anesthesiologist-administered deep sedation for ERCP in average-risk patients. Gastrointest Endosc. 2022 Dec;96(6):983-990.e2. doi: 10.1016/j.gie.2022.06.003. Epub 2022 Jun 9.
• Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S. Dose requirement and complications of diluted and undiluted propofol for deep sedation in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2011 Jun;10(3):313-8. doi: 10.1016/s1499-3872(11)60052-0.
• Liu Y, Yu X, Zhu D, Zeng J, Lin Q, Zang B, Chen C, Liu N, Liu X, Gao W, Guan X. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial. Chin Med J (Engl). 2022 May 5;135(9):1043-1051. doi: 10.1097/CM9.0000000000001912.
• Liu Y, Chen C, Liu N, Tong L, Nie Y, Wu J, Liu X, Gao W, Tang L, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol. Adv Ther. 2021 Oct;38(10):5412-5423. doi: 10.1007/s12325-021-01877-6. Epub 2021 Aug 21.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hypoxia; Propofol; Ciprofol; Intravenous Anesthesia; Elective Endoscopic Retrograde Cholangiopancreatography
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Respiratory; Hypoxia; Biliary Tract Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: C-Anesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No