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The clinical study of Ciprofol in outpatients with painless gastrointestinal endoscopy

The clinical study of Ciprofol in outpatients with painless gastrointestinal endoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047828
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

Gastrointestinal disease

Interventions

control group:Sedation with propofol injection

Sponsors

The Fifth Hospital of Xiamen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. American Anesthesiologist Classification (ASA) I-II; 3. Patients who electively undergo painless gastroscopy and/or colonoscopy; 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 general anesthesia or those who have had a history of anesthesia accident in the past; 2. Known or suspected allergies or contraindications to propofol injection, cyclopofol injection excipients, benzodiazepines, opioids, muscle relaxants, etc.; 3. Patients with acute upper respiratory tract infection, asthma attack or acute severe laryngeal disease; 4. There is a history of gastrointestinal disease: gastrointestinal retention, active bleeding, conditions that may lead to reflux and aspiration; 5. Complicated with craniocerebral loss, intracranial hypertension, stroke, history of cerebrovascular accident, etc.; 6. Respiratory insufficiency, obstructive pulmonary disease, difficult airway or judged to be difficult for endotracheal intubation (modified Markov score grade III or IV); 7. Uncontrolled hypertension, hypotension and diabetes; 8. Severe arrhythmia, heart failure, unstable angina, myocardial infarction, etc.; 9. Severe liver dysfunction or severe renal insufficiency; 10. History of alcoholism or drug dependence; 11. Abuse or long-term use of narcotic, sedative and analgesic drugs; 12. Those who have a history of mental illness in the past; 13. Those who have participated in any drug clinical trials within 1 month before screening; 14. Pregnant and lactating women; fertile women or men who are unwilling to use contraception throughout the trial period; subjects (including male subjects) who have a pregnancy plan within 1 month after the trial; 15. Subjects who are considered by the investigator to have any other factors that are not suitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Onset time;wake up time;Diagnosis success rate;

Countries

China

Contacts

Public ContactRao Rong

The Fifth Hospital of Xiamen

470958196@qq.com+86 13625008552

Outcome results

None listed

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