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Efficacy and safety of ciprofol in induction and maintenance of general anesthesia during day case surgery

Efficacy and safety of ciprofol in induction and maintenance of general anesthesia during day case surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052635
Enrollment
Unknown
Registered
2021-11-02
Start date
2021-11-15
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

anesthesia

Interventions

control group :propofol

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years, gender is not limited; 2. ASA grades are grades I to III; 3.18 kg/m2 <= BMI <= 30kg/m2; 4. Subjects who need elective day surgery under general anesthesia and need tracheal intubation; 5. The subjects voluntarily participated in this trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with contraindications to general anesthesia; 2. Those who plan to undergo general intravenous anesthesia and need to combine other anesthesia methods, such as inhalation anesthesia, spinal anesthesia, nerve block, etc.; 3. Associated with infectious heart diseases such as myocarditis or endocarditis, sepsis; 4. People with craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, history of cerebrovascular accident and central nervous system diseases: mental system diseases (schizophrenia, mania, insanity, etc.) and long-term use of psychiatric drugs Drug history, or other diseases that prevent the measurement of BIS values; 5. Acute heart failure, unstable angina, myocardial infarction within 6 months before screening, resting ECG heart rate = 450ms, female >= 470ms; 6. Abnormal liver and kidney function (ALT or AST >= 2.5 times the upper limit of normal, TBIL >= 1.5 times the upper limit of normal), abnormal renal function (BUN or Urea >= 1.5 times the upper limit of normal, Cr > the upper limit of normal, or 28 years before surgery Dialysis treatment within the past few days), or patients with obvious abnormal coagulation function (PT/APTT/TT higher than the upper limit of normal), anemia or thrombocytopenia (Hb = 160 mmHg, and/or diastolic blood pressure DBP >= 100 mmHg during the screening period); 8. Sitting systolic blood pressure SBP= 11.1 mmol/L during screening period, and/or random blood glucose >= 13.6 mmol/L); 10. History of drug and alcohol abuse within 2 years before the start of the screening period, and alcohol abuse is defined as regular drinking more than 14 times/week (1 time = 150 ml of wine or 360 ml of beer or 45 ml of spirits); 11. Subjects who are judged to have difficulty in airway management, the modified Markov score is grade IV; 12. Known or suspected allergic or contraindicated to various components of the study drug or other benzodiazepines, opioids, propofol, muscle relaxants, etc.; 13. Pregnant or lactating women or subjects (including men) who have childbearing plans within 6 months; 14. Those who have participated in any clinical trial as subjects within 3 months before enrollment; 15. Other conditions judged by the investigator to be unsuitable for inclusion.

Design outcomes

Secondary

MeasureTime frame
The time between the start of medication and the loss of consciousness;bispectralindex values;Time between the end of administration and the patient's awakening;Injection pain score;Extubation time after administration;Anesthesia satisfaction;

Primary

MeasureTime frame
Ratio of successful induction and maintenance of anesthesia;

Countries

China

Contacts

Public ContactHu Yanhui

The Second Affiliated Hospital of Nanchang University

1282254282@qq.com+86 13970911006

Outcome results

None listed

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