Effect of Equivalent Dose of Alfentanil and Sufentanil in Bronchoscopic Treatment

Not Applicable

Completed

• Conditions: Effect of Drug
• Interventions: Drug: Alfentanil

• Registration Number: NCT06414018
• Lead Sponsor: Tongji Hospital

Brief Summary

The equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients

Detailed Description

Afentanil is a powerful, fast-acting narcotic analgesic, which can effectively inhibit intubation reflex. Compared with sufentanil, it has a short half-life and is safer, and can be used as the first choice for short surgical analgesics. In this study, by comparing the use of equivalent dose sufentanil and afentanil combined with laryngeal mask for complex bronchoscopy, the intraoperative analgesic effect and the influence on the recovery of patients were observed, and a better anesthesia scheme was provided for tracheoscopy.

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-14
• Study Start: 2024-05-20
• Primary Completion: 2024-12-25
• Study Completion: 2024-12-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age 18-80,
• ASA I-III level;
• BMI 18.5~23.9;

Exclusion Criteria

• Patients with full stomach and high risk of reflux aspiration;
• Allergic to benzodiazepines, opioids, rocuronium bromide;
• Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
• Pregnant and lactating women;
• severe liver and kidney dysfunction;
• Patients with severe anemia and hypoproteinemia;
• Previous drug use history;
• Recently participated in other clinical studies;
• Patients who cannot cooperate with communication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alfentanil	Alfentanil	The dose of aifentanil group is 10μg/kg
Sufentanil group	Alfentanil	The dose of sufentanil group is 0.2μg/kg

Primary Outcome Measures

Name	Time	Method
time of Recovery	1day	the time from the end of surgery to awake of patient

Secondary Outcome Measures

Name	Time	Method
Time records	1 day	Anesthesia time, induction time, surgical time, awakening time and recovery time
dose of drugs	1 day	The total amount of sedative and analgesic drugs used.
rate of respiratory suppression incidence	1 day	Respiratory frequency\<8 times/min or SP02\<90%
rate of Incidence of Treatment-Emergent Adverse Events	1day	Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc

Trial Locations

Locations (1)

Aijun Xu; 🇨🇳 Hubei, Wuhan, China