Heart disease
Conditions
Interventions
Ciprofol experimental group:NA
Sponsors
Department of Pharmacy, Qingdao Women and Children's Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged 0-18 years (including neonates 1-28 days old and adolescents up to 18 years old), any gender; 2. Scheduled for elective cardiac surgery with similar cardiopulmonary bypass durations (+/-30 minutes); 3. Require intravenous induction of anesthesia with ciprofol monotherapy (meets clinical off-label use criteria with guardian’s informed consent); 4. American Society of Anesthesiologists (ASA) physical status class II–III; 5. Voluntary written informed consent signed by the guardian (if the participant is >=8 years old, additional oral or written assent from the participant is required); 6. Able to cooperate with blood sample collection and complete the 72-hour postoperative follow-up; 7. Essentially normal liver/kidney function, complete blood count, and serum albumin levels (alanine aminotransferase and aspartate aminotransferase =1.5 times the upper limit of normal; serum creatinine within the normal reference range for the corresponding age group).
Exclusion criteria
Exclusion criteria: 1. Intraoperative blood loss exceeding 50 mL. 2. Severe congenital malformations. 3. Abnormal liver, lung, or kidney function; or significant hematologic, endocrine, metabolic, or gastrointestinal diseases. 4. Symptomatic neurological or respiratory diseases. 5. Long-term use of opioids or sedative-hypnotic medications. 6. Children receiving long-term or short-term (within 48 h) drugs or foods that inhibit/induce CYP450 metabolic enzymes (drugs include: erythromycin, clarithromycin, verapamil, rifampicin, HIV protease inhibitors, phenytoin, itraconazole, dexamethasone, phenobarbital, carbamazepine, alcohol; foods include: chocolate, coffee, grapefruit, etc.). 7. Known allergies to eggs, soy products, ciprofol, or propofol; contraindications to propofol, opioids, or their reversal agents. 8. Expected survival time shorter than the treatment duration. 9. Insufficient administration or accurate blood sampling information, or other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inducion time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The successful rate of induction;Number of additional medications and their administration frequency during the surgical procedure;Eyelash reflex disappearance time;Success rate of tracheal intubation;intubation time; | — |
Countries
China
Contacts
Public ContactChang Liu
Department of Pharmacy, Qingdao Women and Children's Hospital, West Liaoyang Road, Qingdao
Outcome results
None listed