Skip to content

Randomized controlled clinical study of efficacy and safety of Ciprofol anesthesia colonoscopy

Randomized controlled clinical study of efficacy and safety of Ciprofol anesthesia colonoscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053626
Enrollment
Unknown
Registered
2021-11-25
Start date
2021-11-24
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

Digestive system disease

Interventions

Experimental group:Ciprofol induction

Sponsors

Department of Anesthesiology, Tianjin Medical University General Hospital, Tianjin Institute of Anesthesiology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 65 years, gender-unrestricted; 2.American Anesthesiologist Classification (ASA) Grade I-II; 3.Body Mass Index (BMI) >= 18 and = 95% when breathing air; systolic blood pressure (SBP) >= 90mmHg and = 60mmHg and = 55 and <= 100 beats/min; 5.Understand the study process and methods, and voluntarily participate in the study.

Exclusion criteria

Exclusion criteria: 1.Patients with contraindications to general anesthesia or those with a previous history of accidental anesthesia; 2.Patients who are known or suspected to be or contraindication to propofol injection, cypofol injection excipients, benzodiazepines, opiates, myisolins and so on; 3.Patients with combined brain loss, intracranial hypertension, stroke, unstable angina pectoris, and myocardial infarction; 4.Respiratory insufficiency, obstructive pulmonary disease, difficult airway, or judged difficult tracheal intubation (Mallampati III or IV); 5.Uncontrolled diabetes mellitus or hypertension; 6.Severe liver dysfunction or severe renal insufficiency; 7.History of alcohol abuse or drug dependence; 8.Abuse or long-term application of anesthetic, sedative and analgesic drugs; 9.A previous history of mental illness; 10.Patients who have participated in any drug clinical trial within 1 month before the screening; 11.Pregnancy and lactating women; fertile women or men are unwilling to have contraception throughout the trial; subjects with pregnancy plans (including males) within 1 month after the trial; 12.Subjects who have any other factors that the investigator considers inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
Anesthesia induction success rate;

Secondary

MeasureTime frame
Duration of successful induction of anesthesia;Eyelash reflection disappear time;Changes in the bispectral index of electroencephalogram;Duration of operation, duration of intubation (from intubation to extubation), duration of stay in monitoring treatment room after anesthesia (modified AIdrete score >=9 points);Study the use of drugs and alternative medicines (including frequency and dosage);Evaluation of anesthesia induction physician satisfaction;

Countries

China

Contacts

Public ContactWang Chenxu

Department of Anesthesiology, Tianjin Medical University General Hospital, Tianjin Institute of Anesthesiology

wangchenxu2836@163.com+86 13920332454

Outcome results

None listed

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