Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP

NCT06015074 | Not Yet Recruiting

• 1 other identifier: C-Anesthesia
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Adverse Effect; Biliary Tract Diseases

Keywords

Ciprofol; Propofol; Intravenous Anesthesia; Elective Endoscopic Retrograde Cholangiopancreatography; Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• the incidence of hypercapnia

  5 minutes each time（base line, 10 minutes after beginning of surgery, completion of surgery, 10 minutes after awakening）

• the incidence of hypotension

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

• sedation-related procedure interruption

  from the induction of anesthesia to completion of ERCP, about 30 minutes

• conversion from intravenous anesthesia to general anesthesia

  from the induction of anesthesia to completion of ERCP, about 30 minutes

• patient satisfaction score

  5 minutes

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

patients in Propofol group receive sufentanil+ propofol

Drug: Propofol

Ciprofol group

EXPERIMENTAL

patients in Ciprofol group receive sufentanil+ ciprofol

Drug: Ciprofol

Interventions

Propofol DRUG

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.

Also known as: Fresenius Kabi，China

Propofol group

Ciprofol DRUG

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.

Also known as: Haisike，China

Ciprofol group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing ERCP, ASA I-III
• normal renal function
• BMI ≥ 18kg/m 2 and ≤ 30kg/m 2

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine,

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (10)

• 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.

  PMID: 15990812 BACKGROUND

• 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.

  PMID: 35690151 BACKGROUND

• 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.

  PMID: 19607937 BACKGROUND

• 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.

  PMID: 21669577 BACKGROUND

• 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.

  PMID: 19422079 BACKGROUND

• 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.

  PMID: 12024135 BACKGROUND

• 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.

  PMID: 18058653 BACKGROUND

• 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.

  PMID: 12105827 BACKGROUND

• 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.

  PMID: 34924506 BACKGROUND

• 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.

  PMID: 34417990 BACKGROUND

MeSH Terms

Conditions

Biliary Tract Diseases; Hypoxia

Interventions

Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Peiying Li, Doctor

  Clinial Research Center, Renji Hospital

  STUDY DIRECTOR

• Yu Weifeng, Doctor

  Department of Anesthesiology, Renji Hospital

  STUDY CHAIR

• Zheng Li, Master

  Department of Anesthesiology, Renji Hospital

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peiying Li, Doctor

CONTACT

15800616866; peiyingli.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: August 29, 2023
• Study Start: June 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)