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A randomized, double-blind, propofol parallel controlled clinical study to evaluate the efficacy and safety of ciprofol emulsion injection on sedation / anesthesia in patients undergoing gynecological short diagnosis and treatment

A randomized, double-blind, propofol parallel controlled clinical study to evaluate the efficacy and safety of ciprofol emulsion injection on sedation / anesthesia in patients undergoing gynecological short diagnosis and treatment

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045764
Enrollment
Unknown
Registered
2021-04-24
Start date
2021-05-17
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

Short and small gynecological diagnosis and treatment

Interventions

Control group:Propofol medium/long chain fat milk injection
Experimental group:Cyclopofol emulsion injection

Sponsors

Shanghai Fengxian District Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Hospitalized patients underling gynecological short diagnosis and treatment; 2.Aged 18 to 65 years, BMI >= 18 and = 90mmHg; Diastolic blood pressure (DBP) >= 60mmHg; Heart rate >= 50 and < 120 bpm; 5.Understanding the procedures and methods of this study, and volunteering to sign the informed consent form and strictly abiding by the clinical trial protocol to complete this study.

Exclusion criteria

Exclusion criteria: 1.Patients with allergic history to eggs, bean products, opioids, drugs with the similar structures to the experimetal drugs, and with suspected genetic history of malignant hyperthermia; 2.Patients with contraindications of the experimetal drugs; 3.Patients who are in pregnant and lactating conditions except for the indications for this operation; or patients who have a pregnancy plan within 1 month after the study; 4.Patients with known or expected difficult airway; 5.Patients with systolic blood pressure (SBP)>=180mmHg and/or diastolic blood pressure (DBP)>=110mmHg, or suffering from severe arrhythmia and unstable angina pectoris, or suffering from myocardial infarction or heart failure in the last 6 months before screening; 6.Patients with a history of respiratory insufficiency, obstructive pulmonary diseases, or acute respiratory infection 1 week before screening; 7.Patients with mental and nervous system diseases (including those with abnormal evaluation of central nervous system function); 8.Patients with uncontrolled diseases with significant clinical significance such as liver, kidney, blood system, nervous system or metabolic system, which may not be suitable for participating in the study; 9.Patients with a suspect or known history of alcohol and drug abuse; 10.Patients who have participated in any drug clinical trials or have a history of anesthesia and surgery within 1 month before screening; 11.Subjects who have any other factors considered by the investigator to be inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Sedation/anesthesia time;

Secondary

MeasureTime frame
Success rate of sedation/anesthesia;Full awake time;Departure time;Drug additional times in induction period;Drug additional times in maintain period;Average additional time;Total amount of drug;Satisfaction of sedation/anesthesia;Adverse events: incidence of adverse events, serious adverse events and adverse reactions;Evaluation of injection pain;Score of MMSE;Evaluation of circulatory system;Evaluation of respiratory system;

Countries

China

Contacts

Public ContactLiu Rong

Shanghai Fengxian District Central Hospital

yaoyuandifang@163.com+86 18018820337

Outcome results

None listed

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