Anesthesia; Adverse EffectNCT06015074
Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP
A study testing Propofol and Ciprofol in people with Anesthesia; Adverse Effect and Biliary Tract Diseases, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia; Adverse Effect, Biliary Tract Diseases
- What is being tested?
- Propofol and Ciprofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing ERCP, ASA I-III
- normal renal function
- BMI ≥ 18kg/m 2 and ≤ 30kg/m 2
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao Tong University School of Medicine,
Shanghai, Shanghai Municipality, 200127
Peiying Li, Doctor, +8615800616866, peiyingli.md@gmail.com
About this study
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.
Read the 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.
- Conditions
- Anesthesia; Adverse Effect, Biliary Tract Diseases
- Being tested
- Propofol, Ciprofol
- Keywords
- Ciprofol, Propofol, Intravenous Anesthesia, Elective Endoscopic Retrograde Cholangiopancreatography, Hypoxia
- Medical subject headings
- Biliary Tract Diseases, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Fresenius Kabi，China
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.
CiprofolDrug
Also called Haisike，China
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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | patients in Propofol group receive sufentanil+ propofol Receives: Drug: Propofol |
| Ciprofol group | Experimental | patients in Ciprofol group receive sufentanil+ ciprofol Receives: Drug: Ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of hypoxia
the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) < 90%
Measured: 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
arterial carbon dioxide partial pressure（PaCO2）>50mmHg
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 30 seconds
length of stay
length of stay in hospital
Measured: 2-7days
the incidence of postoperative adverse bile excretion
patients with symptoms or signs of postoperative adverse bile excretion
Measured: 30 days after operation
the incidence of severe postoperative hypoxia
patients with symptoms or signs of severe postoperative hypoxia
Measured: 30 days after operation
the incidence of severe postoperative circulatory disfunction
patients with symptoms or signs of severe postoperative circulatory disfunction
Measured: 30 days after operation
the incidence of mortality within 30 days after operation
mortality within 30 days after operation
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start15 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peiying Li, Doctor, Study director, Clinial Research Center, Renji HospitalYu Weifeng, Doctor, Study chair, Department of Anesthesiology, Renji HospitalZheng Li, Master, Study director, Department of Anesthesiology, Renji HospitalYanhua Zhao, Doctor, Principal investigator, Department of Anesthesiology, Renji HospitalYifeng Qu, Master, Principal investigator, Department of Anesthesiology, Renji HospitalKun Luo, Master, Principal investigator, Department of Anesthesiology, Renji HospitalGuangyan Wang, Principal investigator, Operating Room，Renji HospitalTeng Wang, Principal investigator, Department of Anesthesiology, Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015074
- Sponsor's protocol ID
- C-Anesthesia
- Status last verified
- May 2024
- First submitted
- 21 Jun 2023
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15990812Alzanbagi 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.
PubMed 35690151Cote 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.
PubMed 19607937Amornyotin 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.
PubMed 21669577Qadeer 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.
PubMed 19422079Vargo 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.
PubMed 12024135Paspatis 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.
PubMed 18058653Vargo 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.
PubMed 12105827Liu 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.
PubMed 34924506Liu 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.
PubMed 34417990
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial.
- ClinicalTrials.gov ID
- NCT06015074
- Acronym / sponsor ID
- C-Anesthesia
- Conditions
- Anesthesia; Adverse Effect, Biliary Tract Diseases
- Keywords
- Ciprofol, Propofol, Intravenous Anesthesia, Elective Endoscopic Retrograde Cholangiopancreatography, Hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: Propofolpatients in Propofol group receive sufentanil+ propofol |
| Ciprofol group | Experimental | Drug: Ciprofolpatients in Ciprofol group receive sufentanil+ ciprofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing ERCP, ASA I-III
- normal renal function
- BMI ≥ 18kg/m 2 and ≤ 30kg/m 2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Fresenius Kabi，Chinapatients 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. | Drug | Propofol group |
| CiprofolAlso: Haisike，Chinapatients 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. | Drug | Ciprofol group |
Primary outcome
the incidence of hypoxia
Time frame: 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%
11 secondary outcomes
the incidence of hypercapnia
Time frame: 5 minutes each time（base line, 10 minutes after beginning of surgery, completion of surgery, 10 minutes after awakening）
the incidence of hypotension
Time frame: from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours
sedation-related procedure interruption
Time frame: from the induction of anesthesia to completion of ERCP, about 30 minutes
conversion from intravenous anesthesia to general anesthesia
Time frame: from the induction of anesthesia to completion of ERCP, about 30 minutes
patient satisfaction score
Time frame: 5 minutes
visual analog scale (VAS) scores
Time frame: 30 seconds
length of stay
Time frame: 2-7days
the incidence of postoperative adverse bile excretion
Time frame: 30 days after operation
the incidence of severe postoperative hypoxia
Time frame: 30 days after operation
the incidence of severe postoperative circulatory disfunction
Time frame: 30 days after operation
the incidence of mortality within 30 days after operation
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background: PubMed 15990812Adler 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.
- Background: PubMed 35690151Alzanbagi 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.
- Background: PubMed 19607937Cote 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.
- Background: PubMed 21669577Amornyotin 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.
- Background: PubMed 19422079Qadeer 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.
- Background: PubMed 12024135Vargo 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.
- Background: PubMed 18058653Paspatis 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.
- Background: PubMed 12105827Vargo 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.
- Background: PubMed 34924506Liu 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.
- Background: PubMed 34417990Liu 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.
- Individual participant dataSharing planned: No
Related trials for Anesthesia; Adverse Effect
RecruitingObservational study
Paramedian Incidence Angles in Spinal Anaesthesia
Anesthesia; Adverse Effect, Spinal and Epidural
Active, not recruitingObservational study
Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Cognitive Decline, Cognitive Change
RecruitingPhase 3
Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)
Anesthesia, Propofol Adverse Reaction
Recruiting
Language During Inhalational Induction
Emergence Delirium, Anesthesia; Adverse Effect
Active, not recruiting
The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery (EPIVA)
Hypospadias, Anesthesia; Adverse Effect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peiying Li, Doctor study director
Clinial Research Center, Renji Hospital
Yu Weifeng, Doctor study chair
Department of Anesthesiology, Renji Hospital
Zheng Li, Master study director
Department of Anesthesiology, Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Ciprofol in people with Anesthesia; Adverse Effect and Biliary Tract Diseases, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peiying Li, Doctor (15800616866, peiyingli.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of hypoxia (time frame: from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015074, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.