Effect of Equivalent Dose of Alfentanil and Sufentanil in Bronchoscopic Treatment (EOEDSAAIBT)

Effect of Equivalent Dose of Alfentanil and Sufentanil Combined With Remimazolam in Complex Bronchoscopic Treatment

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

Study Overview

• Status: Completed
• Conditions: Effect of Drug
• Intervention / Treatment: Drug: Alfentanil

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Wuhan
    • Hubei, Wuhan, China, 430000
      • Aijun Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sufentanil group; The dose of sufentanil group is 0.2μg/kg	Drug: Alfentanil; alfentanil 10ug/kg is used for anesthesia induction; Other Names: sufentanil
Experimental: Alfentanil; The dose of aifentanil group is 10μg/kg	Drug: Alfentanil; alfentanil 10ug/kg is used for anesthesia induction; Other Names: sufentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of Recovery	the time from the end of surgery to awake of patient	1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time records	Anesthesia time, induction time, surgical time, awakening time and recovery time	1 day
dose of drugs	The total amount of sedative and analgesic drugs used.	1 day
rate of respiratory suppression incidence	Respiratory frequency<8 times/min or SP02<90%	1 day
rate of 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of Postoperative adverse reaction	Airway obstruction, hypoxemia, apnea, laryngeal spasm, bronchospasm, cough, postoperative nausea and vomiting, postoperative pain (VAS score), hypotension, bradycardia, dizziness	1 day

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Xinxiang Central Hospital
• Investigators: Principal Investigator: aijun xu, Dr, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Actual): December 25, 2024
• Study Completion (Actual): December 28, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: bronchoscopy; sufentanil; Recovery time; Afentanil
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Sufentanil; Alfentanil
• Other Study ID Numbers: EEDSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: You can request it from the main researcher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No