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A randomized controlled clinical study on the effectiveness and safety of cyclopofol injection in painless gastrointestinal endoscopy

A randomized controlled clinical study on the effectiveness and safety of cyclopofol injection in painless gastrointestinal endoscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046878
Enrollment
Unknown
Registered
2021-05-29
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Gastrointestinal disease

Interventions

Sponsors

The First People's Hospital of Taicang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. American Anesthesiologists (ASA) Grade I-II; 3. Patients who elect to undergo painless gastroscopy and/colonoscopy diagnosis and treatment; 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. Able to understand the research process and methods, and voluntarily participate in this research.

Exclusion criteria

Exclusion criteria: 1. Those who have general anesthesia contraindications or have a history of anesthesia accidents 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 throat disease; 4. Have a history of gastrointestinal diseases: gastrointestinal retention, active bleeding, possible reflux and aspiration, etc.; 5. Combined with history of brain loss, intracranial hypertension, stroke, cerebrovascular accident, etc.; 6. Respiratory insufficiency, obstructive lung disease, difficult airway, or difficulty in tracheal intubation (modified Markov score is 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 alcohol abuse or drug dependence; 11. Abuse or long-term use of narcotic, sedative, and analgesic drugs; 12. Those who have a history of mental illness; 13. Those who have participated in any drug clinical trial within 1 month before screening; 14. Pregnant and lactating patients; patients with fertility are unwilling to use contraception during the entire trial period; patients (including male subjects) who have a pregnancy plan within 1 month after the trial; 15. The investigator believes that there are any other subjects who are not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Gastroscopy/colonoscopy success rate;

Countries

China

Contacts

Public ContactZheng Zhong

The First People's Hospital of Taicang

21957566@qq.com+86 18915768281

Outcome results

None listed

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