Skip to content

Efficacy and safety of ciprofol injection combined with alfentanil for painless gastrointestinal endoscopy: a randomized controlled clinical study

Efficacy and safety of ciprofol injection combined with alfentanil for painless gastrointestinal endoscopy: a randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061132
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Painless gastroenteroscopy

Interventions

Test Group:ciprofol injection

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old, no gender limitation; 2. American Anesthesiologist Classification (ASA) I-II; 3. Patients who are scheduled for 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 volunteer to participate in this research.

Exclusion criteria

Exclusion criteria: 1. Those who have contraindications to general anesthesia or those who have had a history of anesthesia accident; 2. Known or suspected propofol injection, cyclopofol injection excipients, benzodiazepines, opioids 3. Patients with acute upper respiratory tract infection, asthma attack or acute severe laryngeal disease; 4. History of gastrointestinal diseases: gastrointestinal retention, active bleeding, Reflux, aspiration, etc.; 5. Complicated with craniocerebral loss, intracranial hypertension, stroke, cerebrovascular accident history, etc.; 6. Respiratory insufficiency, obstructive pulmonary disease, difficult airway, or trachea Difficulty in intubation (modified Martens 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 with a history of mental illness; 13. Those who have participated in any drug clinical trial within 1 month before screening; 14. regnant and lactating women; women or men with fertility who are unwilling to use contraception throughout the trial period; those who have a pregnancy plan within 1 month after the trial; Subjects (including male subjects); 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
Gastroscopy and colonoscopy success rate;

Secondary

MeasureTime frame
successful duration of anesthesia induction;insertion time;Lens insertion success rate;Duration of gastroscopy/colonoscopy;Fully awake time (time from pulling out the gastroscope/colonoscope to MOAA/S=5);Time of leaving the room (time from removal of gastroscope/colonoscope to Aldrete score =9);Use of study medicines and alternative medicines (including frequency and dose of medicines, etc.);Physician sedation/anesthesia satisfaction evaluation;

Countries

China

Contacts

Public ContactYunqi Lv
Lvyunqi2021@126.com+86 18339253005

Outcome results

None listed

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