A randomized controlled clinical study on the efficacy and safety of cyclopofol injection in monitoring anesthesia during hysteroscopy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100053235

Enrollment

Unknown

Registered

2021-11-16

Start date

2021-11-18

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

None listed

Interventions

Cyclopofol group:Intravenous injection of Ciprofol 0.4mg/kg

Propofol group:Intravenous injection of Propofol 2.0mg/kg

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-45 years; 2. American Anesthesiologist Classification (ASA) I-II; 3. Patients who need MAC for elective hysteroscopy; 4. Body mass index (BMI) >= 18 and =10 and = 95% when breathing air; systolic blood pressure (SBP) >= 90mmHg and = 60mmHg and = 55 and <= 100 beats/min; 6. Be able to understand the research process and methods, and voluntarily participate in this research.

Exclusion criteria

Exclusion criteria: 1. Those with contraindications to intravenous general anesthesia or those who have had a history of anesthesia accident in the past; 2. Known or suspected to be allergic or contraindicated to propofol injection, cyclopofol injection and other excipients; 3. Combined with craniocerebral loss, intracranial hypertension, stroke, unstable angina, myocardial infarction; 4. Respiratory insufficiency, obstructive pulmonary disease, having a difficult airway, or being judged to have difficulty in endotracheal intubation (modified Markov score grade III or IV); 5. Uncontrolled diabetes; 6. Severe liver dysfunction or severe renal insufficiency; 7. History of alcoholism or drug dependence; 8. Abuse or long-term use of narcotic, sedative, and analgesic drugs; 9. Those who have a history of mental illness in the past; 10. Those who have participated in any drug clinical trials within 1 month before screening; 11. Subjects who are considered by the investigator to have any other factors that are not suitable for participating in this trial.

Design outcomes

Primary

Measure	Time frame
Success rate of anesthesia induction;	—

Countries

China

Contacts

Public ContactLiu Yubao

Honghe Ha'ni and Yi Autonomous Prefecture Maternal and Child Health Hospital

1347615807@qq.com+86 13988023116

Outcome results