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Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia

Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05892471
Acronym
seccsa
Enrollment
80
Registered
2023-06-07
Start date
2022-08-01
Completion date
2023-09-01
Last updated
2023-06-07

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

Conditions

Anesthesia

Brief summary

Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia

Interventions

DRUGciprofol injection

Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia

Patients in propofol group received 1.5 mg/kg propofol for induction of anesthesia

Sponsors

Le Yu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Elective surgery patients 2. Aged 55 to 75 3. New York Heart Association class II or III cardiac functions 4. Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures.

Exclusion criteria

1. With a history of benzodiazepine allergy 2. Significant liver or kidney insufficiency 3. Coagulation dysfunction 4. Neurological or psychiatric disorders 5. Undergone major surgery within the past three months.

Design outcomes

Primary

MeasureTime frameDescription
Mean arterial pressure1 second before induction of anesthesia (T1)an average blood pressure in an individual during a single cardiac cycle
Heart beats1 second before induction of anesthesia (T1)the number of times each minute that heart beats

Secondary

MeasureTime frameDescription
Oxygenation index1 second before induction of anesthesia (T1)a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body.
Injection painDuring procedure (When injecting the drug, ask the subject if the injection site is painful)Pain at the injection site when injecting the drug(Evaluation with Visual Analogue Scale)

Countries

China

Contacts

Primary ContactLE YU
907084943@qq.com19921875120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026