CiprofolNCT07081477
Ciprofol's Influence on LVOT VTI in Elderly Painless Colonoscopy Patients
A study testing Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients and Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients in people with Ciprofol, run by The First People's Hospital of Lianyungang.
Trial summary
1. Objective: Primary: Compare the effect of Ciprofol vs Propofol on LVOT VTI at 2 minutes post-injection (T1) in elderly patients (≥65 years). Secondary: Assess hypotension incidence, injection pain, nausea/vomiting, hypoxia (SpO₂≤90%), bradycardia (HR<50 bpm), sedation success rate, induction/recovery times… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ciprofol
- What is being tested?
- Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients and Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2025to 30 Jun 2027
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ASA classification I-III;
- Age ≥65 years and ≤80 years;
- BMI between 18-30 kg/m2 (including the threshold);
- Patients undergoing painless colonoscopy on an elective basis;
- Subjects voluntarily participated in this study and signed an informed consent form.
Who cannot join
- Those with respiratory depression or high risk of respiratory depression (e.g., sleep apnea syndrome, bronchial asthma, etc.);
- Suffering from major diseases such as severe hepatic and renal insufficiency, neurological and psychiatric systems;
- Suffering from severe arrhythmias such as severe aortic regurgitation, atrial fibrillation, tachycardia (heart rate > 120 beats/minute), atrioventricular block of degree II and above, myocardial infarction or unstable angina within 6 months before the examination, and NYHA classification grade II and above;
- Allergy to or abuse of any medication used in the study;
- Participation in another clinical trial within the last 3 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ciprofol on Left Ventricular Outflow Tract Velocity-Time Integral in Elderly Patients Undergoing Painless Colonoscopy
- Objective: Primary: Compare the effect of Ciprofol vs Propofol on LVOT VTI at 2 minutes post-injection (T1) in elderly patients (≥65 years). Secondary: Assess hypotension incidence, injection pain, nausea/vomiting, hypoxia (SpO₂≤90%), bradycardia (HR<50 bpm), sedation success rate, induction/recovery times, procedure duration, drug doses, and patient satisfaction.
- Design: Single-center, randomized, double-blind, controlled trial. Group C (Ciprofol):0.2-0.5 mg/kg IV induction (>30s injection). Group P (Propofol)::1-2 mg/kg IV induction (>30s injection). Rescue doses allowed (C: 0.1 mg/kg; P: 0.5 mg/kg; max 5 doses/15 min).
- Participants: N = 120 elderly patients (65-80 years, ASA I-III, BMI 18-30 kg/m²) scheduled for elective painless colonoscopy. Exclusion: Significant cardiorespiratory, hepatic, renal, or neurological disorders; recent MI/unstable angina (≤6 months); NYHA ≥II; drug allergies; recent trial participation.
- Key Assessments: Primary Endpoint: LVOT VTI (via transthoracic echocardiography, TTE) at T1. Secondary Endpoints: Adverse events (hypotension, pain, nausea/vomiting, hypoxia, bradycardia, body movement, awareness). Sedation success rate, induction/recovery times (MOAA/S scale), procedure time. Drug doses (induction, total, vasoactive agents). Patient satisfaction (5-point scale). LVEF and IVC Collapse Index (TTE at T0, T1, T2). Safety: Vital signs (HR, BP, SpO₂).
- Statistical Analysis:
SPSS 26.0; α=0.05. Methods: t-test, RM-ANOVA, Mann-Whitney U, Chi-square/Fisher's exact, rank-sum tests.
This study aims to determine whether Ciprofol provides superior hemodynamic stability (as measured by LVOT VTI) and fewer adverse effects compared to Propofol for sedation in elderly patients undergoing painless colonoscopy.
- Conditions
- Ciprofol
- Being tested
- Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients, Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients
- Keywords
- Painless colonoscopy, Propofol, Left Ventricular Outflow Tract Velocity Time Integral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly PatientsDrug
Cirpropofol is a 2,6-disubstituted phenol derivative that introduces a cyclopropyl group based on the chemical structure of propofol, increasing its affinity with GABA receptors and stereoeffect, thus its effect is 4-5 times that of propofol. Studies have found that the incidence of hypotension, injection pain, and respiratory depression during cirpropofol anesthesia is lower than that of propofol.
Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly PatientsDrug
Propofol has favorable pharmacokinetic properties with minimal residue. Currently, it is widely used for endoscopic procedure sedation, but there are still many limitations, such as a narrow therapeutic window, injection pain, hypotension, and respiratory depression.
| Study group | Role | What they receive |
|---|---|---|
| During anesthesia induction, ciprofol 0.2-0.5 mg/kg was intravenously injected (injection rate > 30s | Experimental | Group C Receives: Drug: Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients |
| During anesthesia induction, propofol 1-2 mg/kg was intravenously injected (injection rate > 30s). | Active comparator | Group P Receives: Drug: Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular outflow tract velocity time integral
The patient is in the left lateral position, using the same ultrasound equipment with standardized settings (gain, depth, frequency). Transthoracic Doppler echocardiography measurements are taken at the end of expiration.
Measured: Two minutes after administration
Secondary outcomes (10)
Left ventricular outflow tract velocity time integral
The patient is in the left lateral position, using the same ultrasound equipment with standardized settings (gain, depth, frequency). Transthoracic Doppler echocardiography measurements are taken at the end of expiration.
Measured: Perioperative
Left ventricular ejection fraction
The patient is in the left lateral position, using the same ultrasound equipment with standardized settings (gain, depth, frequency). Transthoracic Doppler echocardiography measurements are taken at the end of expiration.
Measured: Perioperative
Inferior Vena Cava Collapse Index
Measure the maximum internal diameter (IVCmax) at end-expiration and minimum internal diameter (IVCmin) at end-inspiration of the inferior vena cava 1-2 cm from the right atrial entrance by ultrasound, and calculate according to the formula (IVCmax - IVCmin)/IVCmax × 100%.
Measured: Perioperative
adverse event
The incidence of hypotension, injection pain, nausea, vomiting, hypoxemia (blood oxygen saturation ≤ 90%), bradycardia (heart rate < 50 beats per minute), body movement (unconscious limb movement of the patient), and intraoperative awareness.
Measured: Perioperative
Induction time
Time from initial administration to Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤1.
Measured: Perioperative
Procedure time
The duration from colonoscopy insertion to withdrawal.
Measured: Perioperative
Awakening time
The time from the end of the last administration to MOAA/S score equaling 5.
Measured: Perioperative
Induction drug dose , additional dose , total dose and vasoactive drug dose
Measured: Perioperative
Sedation success rate
The number of patients who received up to 5 supplemental doses within 15 minutes after completing colonoscopy, without requiring rescue sedation, following the initial dose.
Measured: Perioperative
Patient satisfaction
Patient satisfaction with anesthesia is divided into five options: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start25 Aug 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CiprofolStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081477
- Sponsor's protocol ID
- KY-20250307002-01
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ciprofol on Left Ventricular Outflow Tract Velocity-Time Integral in Elderly Patients Undergoing Painless Colonoscopy
- ClinicalTrials.gov ID
- NCT07081477
- Acronym / sponsor ID
- KY-20250307002-01
- Conditions
- Ciprofol
- Keywords
- Painless colonoscopy, Propofol, Left Ventricular Outflow Tract Velocity Time Integral
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Jul 2025 (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.
- Objective: Primary: Compare the effect of Ciprofol vs Propofol on LVOT VTI at 2 minutes post-injection (T1) in elderly patients (≥65 years). Secondary: Assess hypotension incidence, injection pain, nausea/vomiting, hypoxia (SpO₂≤90%), bradycardia (HR<50 bpm), sedation success rate, induction/recovery times, procedure duration, drug doses, and patient satisfaction.
- Design: Single-center, randomized, double-blind, controlled trial. Group C (Ciprofol):0.2-0.5 mg/kg IV induction (>30s injection). Group P (Propofol)::1-2 mg/kg IV induction (>30s injection). Rescue doses allowed (C: 0.1 mg/kg; P: 0.5 mg/kg; max 5 doses/15 min).
- Participants: N = 120 elderly patients (65-80 years, ASA I-III, BMI 18-30 kg/m²) scheduled for elective painless colonoscopy. Exclusion: Significant cardiorespiratory, hepatic, renal, or neurological disorders; recent MI/unstable angina (≤6 months); NYHA ≥II; drug allergies; recent trial participation.
- Key Assessments: Primary Endpoint: LVOT VTI (via transthoracic echocardiography, TTE) at T1. Secondary Endpoints: Adverse events (hypotension, pain, nausea/vomiting, hypoxia, bradycardia, body movement, awareness). Sedation success rate, induction/recovery times (MOAA/S scale), procedure time. Drug doses (induction, total, vasoactive agents). Patient satisfaction (5-point scale). LVEF and IVC Collapse Index (TTE at T0, T1, T2). Safety: Vital signs (HR, BP, SpO₂).
- Statistical Analysis:
SPSS 26.0; α=0.05. Methods: t-test, RM-ANOVA, Mann-Whitney U, Chi-square/Fisher's exact, rank-sum tests.
This study aims to determine whether Ciprofol provides superior hemodynamic stability (as measured by LVOT VTI) and fewer adverse effects compared to Propofol for sedation in elderly patients undergoing painless colonoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| During anesthesia induction, ciprofol 0.2-0.5 mg/kg was intravenously injected (injection rate > 30s | Experimental | Drug: Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly PatientsGroup C |
| During anesthesia induction, propofol 1-2 mg/kg was intravenously injected (injection rate > 30s). | Active comparator | Drug: Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly PatientsGroup P |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ASA classification I-III;
- Age ≥65 years and ≤80 years;
- BMI between 18-30 kg/m2 (including the threshold);
- Patients undergoing painless colonoscopy on an elective basis;
- Subjects voluntarily participated in this study and signed an informed consent form.
Key exclusion criteria (5 listed)
- Those with respiratory depression or high risk of respiratory depression (e.g., sleep apnea syndrome, bronchial asthma, etc.);
- Suffering from major diseases such as severe hepatic and renal insufficiency, neurological and psychiatric systems;
- Suffering from severe arrhythmias such as severe aortic regurgitation, atrial fibrillation, tachycardia (heart rate > 120 beats/minute), atrioventricular block of degree II and above, myocardial infarction or unstable angina within 6 months before the examination, and NYHA classification grade II and above;
- Allergy to or abuse of any medication used in the study;
- Participation in another clinical trial within the last 3 months.
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 |
|---|---|---|
| Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly PatientsCirpropofol is a 2,6-disubstituted phenol derivative that introduces a cyclopropyl group based on the chemical structure of propofol, increasing its affinity with GABA receptors and stereoeffect, thus its effect is 4-5 times that of propofol. Studies have found that the incidence of hypotension, injection pain, and respiratory depression during cirpropofol anesthesia is lower than that of propofol. | Drug | During anesthesia induction, ciprofol 0.2-0.5 mg/kg was intravenously injected (injection rate > 30s |
| Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly PatientsPropofol has favorable pharmacokinetic properties with minimal residue. Currently, it is widely used for endoscopic procedure sedation, but there are still many limitations, such as a narrow therapeutic window, injection pain, hypotension, and respiratory depression. | Drug | During anesthesia induction, propofol 1-2 mg/kg was intravenously injected (injection rate > 30s). |
Primary outcome
Left ventricular outflow tract velocity time integral
Time frame: Two minutes after administration
The patient is in the left lateral position, using the same ultrasound equipment with standardized settings (gain, depth, frequency). Transthoracic Doppler echocardiography measurements are taken at the end of expiration.
10 secondary outcomes
Left ventricular outflow tract velocity time integral
Time frame: Perioperative
Left ventricular ejection fraction
Time frame: Perioperative
Inferior Vena Cava Collapse Index
Time frame: Perioperative
adverse event
Time frame: Perioperative
Induction time
Time frame: Perioperative
Procedure time
Time frame: Perioperative
Awakening time
Time frame: Perioperative
Induction drug dose , additional dose , total dose and vasoactive drug dose
Time frame: Perioperative
Sedation success rate
Time frame: Perioperative
Patient satisfaction
Time frame: Perioperative
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 23 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients and Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients in people with Ciprofol, run by The First People's Hospital of Lianyungang.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 zhibin Zhao (18961326661, lygzhaozhibin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular outflow tract velocity time integral (time frame: Two minutes after administration). 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 23 Jul 2025.