AnesthesiaAnricofen CiprNCT07376577
Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
A study testing Sufentanil, Anricofen and Ciprofol in people with Anesthesia and Sedation, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a key technique for treating pancreatobiliary diseases in the elderly. However, traditional sedative and analgesic regimens (e.g., sufentanil combined with propofol) are associated with a high incidence of respiratory depression, postoperative nausea… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Anesthesia, Sedation, ERCP
- What is being tested?
- Sufentanil, Anricofen and Ciprofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Age 60-90 years.
- American Society of Anesthesiologists (ASA) physical status II or III.
- Scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP).
- Body mass index (BMI) between 18 and 30 kg/m².
- Willing and able to provide written informed consent.
Who cannot join
- Severe neurological disorders (acute stroke, uncontrolled seizures, epilepsy).
- Psychiatric disorders or cognitive impairment (Mini-Mental State Examination score <24).
- Uncontrolled hypertension (preoperative blood pressure ≥180/110 mmHg) or hypotension (<90/60 mmHg).
- Severe cardiac disease: sinus bradycardia, sick sinus syndrome, unstable angina, or myocardial infarction within the past 3 months.
- Severe hepatic or renal dysfunction.
- Difficult airway or severe respiratory disease.
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- Achalasia.
- Known allergy to anricofen, sufentanil, ciprofol, or other study medications.
- Use of opioid analgesics or sedatives within 7 days prior to surgery.
- Preoperative pulse oxygen saturation (SpO₂) <90% on room air.
- Pregnancy or lactation.
- Participation in any other drug clinical trial within the past 3 months.
- Refusal to participate in the study.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan
About this study
Official title: A Randomized Controlled Trial on the Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography
Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a key technique for treating pancreatobiliary diseases in the elderly. However, traditional sedative and analgesic regimens (e.g., sufentanil combined with propofol) are associated with a high incidence of respiratory depression, postoperative nausea and vomiting (PONV), and delayed recovery in elderly patients. Anricofen is a novel peripherally selective κ-opioid receptor agonist that provides analgesia with minimal central respiratory depression. Ciprofol is a new sedative agent characterized by rapid onset and quick recovery. The combination of these two drugs may offer a safer sedation and analgesia regimen for elderly patients undergoing ERCP.
Objective: To evaluate the efficacy and safety of anricofen combined with ciprofol for deep sedation in elderly patients undergoing ERCP, compared with the traditional regimen (sufentanil combined with ciprofol).
Read more
Methods: This is a single-center, randomized, double-blind, controlled trial. A total of 141 elderly patients aged 60-90 years with ASA physical status II-III scheduled for elective ERCP will be enrolled and randomly assigned in a 1:1:1 ratio to three groups: Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg, Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg, or Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg. The primary efficacy endpoint is the intraoperative pain control success rate (proportion of time with Behavioral Pain Scale [BPS] score ≤3 ≥90%). The primary safety endpoint is the incidence of respiratory depression (respiratory rate <10 breaths/min or SpO₂ <90% requiring intervention). Secondary outcomes include sedation depth, body movement episodes, recovery time, PONV incidence, and others.
Significance: This study aims to provide a sedation and analgesia regimen with lower risk of respiratory depression and faster recovery for elderly patients undergoing ERCP.
- Conditions
- Anesthesia, Sedation, ERCP, Ciprofol
- Being tested
- Sufentanil, Anricofen, Ciprofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Sufentanil is a potent synthetic opioid analgesic acting primarily on μ-opioid receptors. It is commonly used for analgesia during surgical and endoscopic procedures. In this study, it serves as the active comparator in combination with ciprofol. It is administered intravenously.
AnricofenDrug
Anricofen is a novel peripherally selective κ-opioid receptor agonist. It provides analgesia primarily through peripheral mechanisms with minimal central nervous system penetration, thereby reducing the risk of respiratory depression and addiction compared to traditional μ-opioid agonists. It is administered intravenously.
CiprofolDrug
Ciprofol is a novel intravenous sedative agent with higher lipophilicity than propofol, leading to faster onset and recovery. It exhibits less cardiovascular depression compared to propofol and is suitable for procedural sedation, particularly in elderly patients. It is administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg | Experimental | Not described Receives: Drug: Anricofen; Drug: Ciprofol |
| Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg | Experimental | Not described Receives: Drug: Anricofen; Drug: Ciprofol |
| Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg | Active comparator | Participants receive intravenous sufentanil at a dose of 0.1 μg/kg (standard clinical dose) combined with ciprofol at 1.0 mg/kg for induction of deep sedation prior to ERCP. This regimen serves as the active control. Supplemental doses (one-third of the initial sufentanil dose and one-fourth of the initial ciprofol dose) may be administered during the procedure if needed based on behavioral pain score (BPS >3) or body movements. Receives: Drug: Sufentanil; Drug: Anricofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Pain Control Success Rate
Measured: During the ERCP procedure (from induction to end of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376577
- Sponsor's protocol ID
- XYFY-IIT-ANES-ERCP-2025-01
- Acronym
- Anricofen Cipr
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT07376577
- Acronym / sponsor ID
- Anricofen Cipr / XYFY-IIT-ANES-ERCP-2025-01
- Conditions
- Anesthesia, Sedation, ERCP, Ciprofol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 29 Jan 2026 (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.
Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a key technique for treating pancreatobiliary diseases in the elderly. However, traditional sedative and analgesic regimens (e.g., sufentanil combined with propofol) are associated with a high incidence of respiratory depression, postoperative nausea and vomiting (PONV), and delayed recovery in elderly patients. Anricofen is a novel peripherally selective κ-opioid receptor agonist that provides analgesia with minimal central respiratory depression. Ciprofol is a new sedative agent characterized by rapid onset and quick recovery. The combination of these two drugs may offer a safer sedation and analgesia regimen for elderly patients undergoing ERCP.
Objective: To evaluate the efficacy and safety of anricofen combined with ciprofol for deep sedation in elderly patients undergoing ERCP, compared with the traditional regimen (sufentanil combined with ciprofol).
Methods: This is a single-center, randomized, double-blind, controlled trial. A total of 141 elderly patients aged 60-90 years with ASA physical status II-III scheduled for elective ERCP will be enrolled and randomly assigned in a 1:1:1 ratio to three groups: Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg, Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg, or Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg. The primary efficacy endpoint is the intraoperative pain control success rate (proportion of time with Behavioral Pain Scale [BPS] score ≤3 ≥90%). The primary safety endpoint is the incidence of respiratory depression (respiratory rate <10 breaths/min or SpO₂ <90% requiring intervention). Secondary outcomes include sedation depth, body movement episodes, recovery time, PONV incidence, and others.
Significance: This study aims to provide a sedation and analgesia regimen with lower risk of respiratory depression and faster recovery for elderly patients undergoing ERCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg | Experimental | Drug: Anricofen, Drug: Ciprofol |
| Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg | Experimental | Drug: Anricofen, Drug: Ciprofol |
| Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg | Active comparator | Drug: Sufentanil, Drug: AnricofenParticipants receive intravenous sufentanil at a dose of 0.1 μg/kg (standard clinical dose) combined with ciprofol at 1.0 mg/kg for induction of deep sedation prior to ERCP. This regimen serves as the active control. Supplemental doses (one-third of the initial sufentanil dose and one-fourth of the initial ciprofol dose) may be administered during the procedure if needed based on behavioral pain score (BPS >3) or body movements. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -
- Age 60-90 years.
- American Society of Anesthesiologists (ASA) physical status II or III.
- Scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP).
- Body mass index (BMI) between 18 and 30 kg/m².
Key exclusion criteria (14 listed)
- Severe neurological disorders (acute stroke, uncontrolled seizures, epilepsy).
- Psychiatric disorders or cognitive impairment (Mini-Mental State Examination score <24).
- Uncontrolled hypertension (preoperative blood pressure ≥180/110 mmHg) or hypotension (<90/60 mmHg).
- Severe cardiac disease: sinus bradycardia, sick sinus syndrome, unstable angina, or myocardial infarction within the past 3 months.
- Severe hepatic or renal dysfunction.
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 |
|---|---|---|
| SufentanilSufentanil is a potent synthetic opioid analgesic acting primarily on μ-opioid receptors. It is commonly used for analgesia during surgical and endoscopic procedures. In this study, it serves as the active comparator in combination with ciprofol. It is administered intravenously. | Drug | Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg |
| AnricofenAnricofen is a novel peripherally selective κ-opioid receptor agonist. It provides analgesia primarily through peripheral mechanisms with minimal central nervous system penetration, thereby reducing the risk of respiratory depression and addiction compared to traditional μ-opioid agonists. It is administered intravenously. | Drug | Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg, Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg, Sufentanil 0.1 μg/kg + Ciprofol 1.0 mg/kg |
| CiprofolCiprofol is a novel intravenous sedative agent with higher lipophilicity than propofol, leading to faster onset and recovery. It exhibits less cardiovascular depression compared to propofol and is suitable for procedural sedation, particularly in elderly patients. It is administered intravenously. | Drug | Anricofen 0.3 μg/kg + Ciprofol 1.0 mg/kg, Anricofen 0.5 μg/kg + Ciprofol 1.0 mg/kg |
Primary outcome
Intraoperative Pain Control Success Rate
Time frame: During the ERCP procedure (from induction to end of procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil, Anricofen and Ciprofol in people with Anesthesia and Sedation, run by The First Affiliated Hospital of Xinxiang Medical College 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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longhua Guo (18303733012, 1535732839@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Pain Control Success Rate (time frame: During the ERCP procedure (from induction to end of procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.