Ciprofol
Conditions
Keywords
Painless colonoscopy, Propofol, Left Ventricular Outflow Tract Velocity Time Integral
Brief 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, procedure duration, drug doses, and patient satisfaction. 2. 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). 3. 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. 4. 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). 5. 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.
Interventions
DRUGIntravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients
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.
DRUGPropofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients
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.
Sponsors
The First People's Hospital of Lianyungang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. ASA classification I-III; 2. Age ≥65 years and ≤80 years; 3. BMI between 18-30 kg/m2 (including the threshold); 4. Patients undergoing painless colonoscopy on an elective basis; 5. Subjects voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
1. Those with respiratory depression or high risk of respiratory depression (e.g., sleep apnea syndrome, bronchial asthma, etc.); 2. Suffering from major diseases such as severe hepatic and renal insufficiency, neurological and psychiatric systems; 3. 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; 4. Allergy to or abuse of any medication used in the study; 5. Participation in another clinical trial within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular outflow tract velocity time integral | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction | Perioperative | 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. |
| Inferior Vena Cava Collapse Index | Perioperative | 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%. |
| adverse event | Perioperative | 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. |
| Induction time | Perioperative | Time from initial administration to Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤1. |
| Left ventricular outflow tract velocity time integral | Perioperative | 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. |
| Awakening time | Perioperative | The time from the end of the last administration to MOAA/S score equaling 5. |
| Induction drug dose , additional dose , total dose and vasoactive drug dose | Perioperative | — |
| Sedation success rate | Perioperative | 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. |
| Patient satisfaction | Perioperative | Patient satisfaction with anesthesia is divided into five options: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. |
| Procedure time | Perioperative | The duration from colonoscopy insertion to withdrawal. |
Contacts
Primary Contactzhibin Zhao
Outcome results
None listed