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Efficacy and safety of ciprofol for induction of general anesthesia in patients undergoing carotid endarterectomy: a randomized, double-blind, propofol-controlled clinical trial

Efficacy and safety of ciprofol for induction of general anesthesia in patients undergoing carotid endarterectomy: a randomized, double-blind, propofol-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074297
Enrollment
Unknown
Registered
2023-08-03
Start date
2023-08-15
Completion date
Unknown
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid endarterectomy in patients with coronary artery disease

Interventions

Test group 1:ciprofol 0.3 mg/kg for induction of general anesthesia
Test group 2:ciprofol 0.4 mg/kg for induction of general anesthesia
Control group:Propofol 2.0mg/kg for general anesthesia induction

Sponsors

General Hospital of the Northern War Zone of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age >18 years, regardless of gender; 2) Stenosis of more than 1 coronary artery vessel confirmed by coronary artery-related tests (coronary angiography or coronary CT) narrowing of >50%; (3) unilateral carotid artery stenosis of 70% to 99% or unilateral carotid artery stenosis of 50% to 69% with clinical symptoms. (4) American Society of Anesthesiologists (ASA) classification of I-III; (5) cardiac function (NYHA) class I-III; 6) BMI of 18-30 kg/m2; 7) complete perioperative information; 8) voluntary signed informed consent;

Exclusion criteria

Exclusion criteria: 1) Known hypersensitivity to the active ingredients or excipients of ciprofol or propofol injection 2) Combination of other cardiac diseases ( congenital heart disease, rheumatic heart disease, pulmonary heart disease, cardiomyopathy, valvular disease, etc.); 3) non-atherosclerotic carotid stenosis such as fibromuscular dysplasia, aortitis, carotid body aneurysm; 4) those with previous CEA or carotid artery stenting (carotid artery stenting, CAS); 5) Patients with difficult airways, patients with modified Mallampati classification grade IV; 6) Patients who are pregnant or breastfeeding; patients with planned pregnancy within 1 month after surgery 7) moderate to severe hepatic impairment or concomitant hepatic enzyme induction/inhibitors (including within 2 weeks of discontinuation); renal dysfunction (blood creatinine >177 µmol/L); 8) Patients with severe impairment of consciousness or presence of psychiatric system disorders (schizophrenia, mania, bipolar abnormalities, psychosis, etc.) and cognitive dysfunction; 9) previous hematologic disorders, malignant tumors; 10) chronic substance abusers, patients with a history of sedative/narcotic drug use within 1 month 11) Patients with significantly abnormal preoperative physical examination or laboratory test results;

Design outcomes

Primary

MeasureTime frame
area under baseline of mean arterial pressure after administration;

Secondary

MeasureTime frame
heart rate;systolic blood pressure;diastolic blood pressure;cardiac index;stroke volume variation ;systemic vascular resistance index;successful induction rate of general anesthesia;time to successful induction of general anesthesia;change in cerebral oxygen saturation;change in bispectral index value;

Countries

China

Contacts

Public ContactQiang Jin

General Hospital of the Northern War Zone of the Chinese People's Liberation Army

jinqiang1972@126.com+86 177 9099 3977

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026