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Safety and efficacy of alfentanil in interventional surgery for lower extremity arteriosclerosis obliterans

Safety and efficacy of alfentanil in interventional surgery for lower extremity arteriosclerosis obliterans

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054991
Enrollment
Unknown
Registered
2021-12-30
Start date
2022-01-20
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

lower extremity arteriosclerosis obliterans disease

Interventions

AP group:Induction: Alfentanil 10 µg + Propofol 2 mg/kg
Maintenance: Alfentanil 30 µg/kg/h + Propofol 2-4 mg/kg/h
FP group:Induction: Fentanyl 1.5 µg/kg + Propofol 2 mg/kg
Maintenance: Fentanyl 4.5 µg/kg/h + Propofol 2-4 mg/kg/h

Sponsors

Affiliated Cardiovascular Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who were diagnosed with lower extremity arteriosclerosis obliterans by examination in our hospital and needed interventional surgery; 2. The ASA classification of all patients is grade II-III; 3. All patients underwent thoracotomy for the first time; 4. The patient has no congenital heart disease; 5. The patient is conscious and can communicate normally; 6. Voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The subject expressly refuses to participate in this research; 2. Those who are allergic to opioids and propofol excipients; 3. Use of beta-blockers, anxiolytics, and antidepressants; 4. Suspected abuse of narcotic analgesics or sedatives, and alcoholics; 5. A history of acute respiratory tract infection that has not been cured within 2 weeks; 6. Subjects with previous chronic obstructive pulmonary disease; 7. Those with a history of severe heart, brain, lung, liver, kidney or metabolic diseases, those with neuromuscular diseases (such as myasthenia gravis), and mental illnesses; 8. Systolic blood pressure >180 mmHg and (or) diastolic blood pressure >110 mmHg in subjects with preoperative hypertension, or blood pressure <90/60 mmHg in subjects with hypotension; 9. Those who have a history of abnormal surgical anesthesia recovery in the past; 10. It is predicted that difficult airway may occur or has occurred, such as modified Markov classification 3-4; 11. Pregnant or lactating subjects and subjects (including men) who have childbearing plans within 3 months; 12. Subjects who are considered unsuitable for participation in this study by other researchers.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative hypoxemia;

Countries

China

Contacts

Public ContactYan Pianpian

Affiliated Cardiovascular Hospital of Xiamen University

64891809@qq.com+86 13459015579

Outcome results

None listed

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