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A randomized controlled clinical study on the efficacy and safety of ciprofol injection in inducing general anesthesia in patients undergoing gynecological surgery

A randomized controlled study on the efficacy and safety of ciprofol in inducing general anesthesia during gynecological surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045211
Enrollment
Unknown
Registered
2021-04-08
Start date
2021-12-01
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

Induction of general anesthesia in gynecological surgery

Interventions

Experimental group:Cyclopofol injection

Sponsors

Sichuan Provincial Women's and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, no gender limitation; 2. American Society of Anesthesiologists (ASA) Grade I-II; 3. Patients requiring endotracheal intubation general anesthesia for elective surgery; 4. Body mass index (BMI) >=18 kg/m^2 and =10 and = 95% when breathing air; Systolic blood pressure (SBP) >=90 mmHg and = 60mmHg and =55 and <=100 beats/min; 6. Can understand the process and method of this study, and volunteer to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to general anesthesia or with previous history of anesthesia accidents; 2. Patients who are known or suspected to be allergic or contraindicated to propofol injection, cyclopofol injection excipients, benzodiazepines, opioids, muscle relaxants, etc.; 3. Patients with complicated craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris or myocardial infarction; 4. Resrespiratory insufficiency, obstructive pulmonary disease, presence of difficult airway, or judged tracheal intubation difficulty (modified Markov score grade III or IV); 5. Uncontrolled diabetes or hypertension; 6. With severe liver dysfunction or severe renal insufficiency; 7. With a history of alcohol abuse or drug dependence; 8. Abuse or long-term use of narcotic, sedative and analgesic drugs; 9. Patients with a history of mental illness; 10. Patients who had participated in any drug clinical trial within 1 month before screening; 11. Pregnant and lactating women;Fertile women or men were reluctant to use contraception throughout the trial;Subjects (including male subjects) who plan to become pregnant within 1 month after the trial; 12. Patients who, in the opinion of the Investigator, have any other factors that are not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Success rate of anesthesia induction;Duration of successful anesthesia induction;Length of disappearance of eyelash reflex;Changes of bispectral index ;

Countries

China

Contacts

Public ContactChen Benzhen

Sichuan Provincial Women's and Children's Hospital

chenbenzhen@163.com+86 13408669172

Outcome results

None listed

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