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The efficacy and safety of alfentanil in painless endoscopy

The efficacy and safety of alfentanil in painless endoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083522
Enrollment
Unknown
Registered
2024-04-26
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

painless endoscopy

Interventions

A:Alfentanil 5 µg/kg was slowly injected intravenously for more than 10 s. After 30 s, ciprofol was injected intravenously
B:Alfentanil 7 µg/kg was slowly injected intravenously for more than 10 s. After 30 s, ciprofol was injected intravenously
C:Alfentanil 10 µg/kg was slowly injected intravenously for more than 10 s. After 30 s, ciprofol was injected intravenously

Sponsors

The Affiliated Suzhou Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) patients undergoing elective painless gastroscopy or colonoscopy 2) Age of 18-60 years old, both sexes 3) BMI : 18.5-28 kg/m2 4) American Society of Anesthesiologists (ASA) grade I-II 5) The operation time should be within 45 minutes 6) The subjects voluntarily participated in the trial and signed the informed consent for this trial

Exclusion criteria

Exclusion criteria: 1) The subjects explicitly refused to participate in the study 2) allergy to opioids, benzodiazepines, cyclopropofol, flumazenil or naloxone 3) use of ß-blockers, anxiolytics and antidepressants 4) suspected abuse of narcotic analgesics or sedatives, and alcohol abuse 5) ECG: heart rate 100 beats /min, or severe arrhythmia 6) a history of acute respiratory infection without cure within 2 weeks 7) patients with a history of serious heart, brain, lung, liver, kidney or metabolic diseases, neuromuscular diseases (such as myasthenia gravis), or psychiatric diseases 8) systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg in patients with hypertension, or <90/60 mmHg in patients with hypotension 9) patients with a history of gastrointestinal diversion 10) patients with a history of abnormal anesthesia recovery 11) predicted that difficult airway might occur or had occurred in the past, such as modified Maanobis classification ?-? 12) pregnant or lactating women and patients (including men) who plan to have children within 3 months 13) other subjects who were deemed by the investigators to be inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
SpO2;respiratory rate;

Secondary

MeasureTime frame
NBP;heart rate;Ciprofol add times;Ciprofol dosage;

Countries

CHINA

Contacts

Public ContactGu Chengyong

The Affiliated Suzhou Hospital of Nanjing Medical University

gcygcy1979@163.com+86 138 6216 9052

Outcome results

None listed

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