Anesthesia; Adverse Effect Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 136 |
Est. completion date | February 28, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Renji Hospital, Shanghai Jiao Tong University School of Medicine, | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | patient satisfaction score | Patients' satisfaction score is measured by patient recovery satisfaction score, from -33 the worst to 33 the best. | 5 minutes | |
Secondary | 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 | |
Secondary | length of stay | length of stay in hospital | 2-7days | |
Secondary | the incidence of postoperative adverse bile excretion | patients with symptoms or signs of postoperative adverse bile excretion | 30 days after operation | |
Secondary | the incidence of severe postoperative hypoxia | patients with symptoms or signs of severe postoperative hypoxia | 30 days after operation | |
Secondary | the incidence of severe postoperative circulatory disfunction | patients with symptoms or signs of severe postoperative circulatory disfunction | 30 days after operation | |
Secondary | the incidence of mortality within 30 days after operation | mortality within 30 days after operation | 30 days after operation |
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