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A Prospective Efficacy Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Ciprofol Injection for the Induction and Maintenance of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery

A Prospective Efficacy Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Ciprofol Injection for the Induction and Maintenance of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085640
Enrollment
Unknown
Registered
2024-06-14
Start date
2023-04-20
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Anesthesia

Interventions

ciprofol:Intravenous push and/or infusion

Sponsors

Hu'nan Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1)Age =2 years and <18 years, pediatric males or pediatric females; 2)Pediatric population whose type of surgery is elective, with a duration of at least 20 minutes, requiring a general anesthesia surgical procedure with mechanical ventilation by endotracheal intubation, and where no blood transfusion is expected to be planned; 3)Children who are using ciprofol during both induction and maintenance of general anesthesia; 4) ASA score of I-II; 5) Signed informed consent prior to the start of any activities related to the trial.

Exclusion criteria

Exclusion criteria: 1)Pediatric patients whose type of surgery is an emergency rescue surgery or who require emergency resuscitation during surgery; 2)Pediatric patients who are intolerant or allergic to ciprofol; 3) Pediatric patients who have received other anesthetic drugs or drugs that affect the metabolism of experimental drugs within 1 week; 4) Pediatric patients who are not suitable for general intravenous anesthesia; 5) Pediatric patients who, in the opinion of the investigator, should not participate in the trial.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic;

Secondary

MeasureTime frame
Success rate of anesthesia induction;Success rate of anesthesia maintenance;Duration of successful induction of anesthesia;Duration of loss of eyelash reflex;Depth of anesthesia assessment;Duration of awakening;Duration to extubation;Duration of PACU stay;Evaluation of general anesthesia satisfaction;

Countries

China

Contacts

Public ContactZheng Chen

Hu'nan Children's Hospital

czok@sina.com+86 139 7492 5507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026