A Multicenter, Open, Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cipepofol Injection for General Anesthesia in Pediatric Patients Undergoing Elective Surgery

Anesthesia Clinical Trial

Official title:

A Multicenter, Open, Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cipepofol Injection for General Anesthesia in Pediatric Patients Undergoing Elective Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391931
• Other study ID #: HSK3486-310
• Status: Recruiting
• Phase: Phase 3
• Start date: April 7, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2024
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: Zhang Mazhong, Doctor
• Phone: +86 21 3862 5981
• Email: zmzscmc[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter, open, controlled, Phase III clinical study to evaluate the efficacy and safety of Cipepofol injection for general anesthesia in pediatric patients undergoing elective surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age =2 years old and < 18 years old, gender is not limited;

• Selective surgery requiring tracheal intubation, mechanical ventilation and general anesthesia, with an estimated anesthetic time of 30 to 120 minutes;

• Intravenous anesthesia is suitable for both induction and maintenance of general anesthesia;

• ASA grade I-II;

• Before any activities related to the trial, the child's guardian or his/her guardian should sign the informed consent.

Exclusion Criteria:

• The type of operation is emergency rescue operation or emergency rescue is required during the operation or blood transfusion may be required according to the researchers;

• Patients with contraindications to general anesthesia or who have a history of anesthesia accidents;

• Known or suspected allergy to excipients in propofol injection, Cipepofol injection excipients (soybean oil, glycerol, triglyceride, yolk lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, atropine, etc., and their active ingredients; Contraindications of propofol injection;

• Prior to screening/baseline, the following medical history or evidence of increased risk of sedation/anesthesia was collected and was determined by the investigator to be inappropriate: Cardiovascular system diseases: severe congenital heart disease (such as tetralogy of Fallot, etc.), severe arrhythmias (such as tachycardia/bradycardia requiring medical treatment, degree III atrioventricular block), severe heart failure, etc.; Respiratory diseases: respiratory insufficiency, history of bronchospasm/asthma requiring treatment within 1 month prior to screening, acute upper respiratory infection with obvious fever, wheezing, or phlegm-producing cough within 1 week prior to baseline; Craniocerebral diseases: history of craniocerebral injury, convulsion, epilepsy, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; Or a known history of mental disorders, such as seizures, schizophrenia, mania, long-term use of psychiatric drugs, cognitive dysfunction; Gastrointestinal diseases: gastrointestinal retention, active bleeding, may lead to reflux aspiration and other conditions; a history of uncontrolled, clinically significant disease of the liver, kidney, hematological, nervous, or metabolic system; Patients with severe infection, trauma or major surgical operation within 4 weeks prior to screening; A history or family history of malignant hyperthermia.

• There are any of the following respiratory management risks within 1 week before screening: Asthma attacks, wheezing; Patients with failed tracheal intubation experience; The investigators assessed the risk of difficulty with mask ventilation or intubation.

• Participants who have participated in any drug clinical trial within 1 month before screening;

• Laboratory examination indicators in the screening period/baseline period meet the following standards and are confirmed by review: alanine aminotransferase and/or ASpartate aminotransferase = 5.0× Upper limit of normal (ULN); Total bilirubin =3.0×ULN; serum creatinine =2.5×ULN.

• Women who are fertile (i.e. post-menarche) and do not wish to use contraception throughout the trial period;

• Paediatric population requiring special care or supervision by courts/social welfare institutions;

• Subjects who have any other factors deemed unsuitable by the investigator for participation in this study.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Cipepofol
0.6±0.2 mg/kg induce + 0.8 mg/kg/h maintain
• Propofol
3.0 mg/kg induce + 5.0 mg/kg/h maintain

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of anesthesia	Success rate of anesthesia induction and anesthesia maintenance	24 hours after the end of surgery