Effect of Equivalent Dose Sufentanil and Afentanil in Bronchoscopic Treatment

Effect of Drug Clinical Trial

— EOEDSAAIBT  

Official title:

Effect Observation of Equivalent Dose Sufentanil and Afentanil Combined Laryngeal Mask for Complex Bronchoscopic Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06414018
• Other study ID #: EEDSA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: mujun chang, doctor
• Phone: 86-27-83663625
• Email: changmujun[@]hotmial.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 28, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Drug

Intervention

Drug:
• Alfentanil
alfentanil 10ug/kg is used for anesthesia induction

Locations

Country	Name	City	State
China	Aijun Xu	Hubei	Wuhan

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	Xinxiang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative adverse reaction	Airway obstruction, hypoxemia, apnea, laryngeal spasm, bronchospasm, cough, postoperative nausea and vomiting, postoperative pain (VAS score), hypotension, bradycardia, dizziness	1 day
Primary	Recovery time	the time from the end of surgery to awake of patient	1day
Secondary	Time records	Anesthesia time, induction time, surgical time, awakening time and recovery time	1 day
Secondary	dose of drugs	The total amount of sedative and analgesic drugs used.	1 day
Secondary	Respiratory suppression incidence	Respiratory frequency<8 times/min or SP02<90%	1 day
Secondary	Incidence of Treatment-Emergent Adverse Events	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	1day