Effect of Equivalent Dose of Alfentanil and Sufentanil in Bronchoscopic Treatment

NCT06414018 | Completed

• 1 other identifier: EEDSA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Effect of Drug

Keywords

Afentanil; sufentanil; bronchoscopy; Recovery time

Outcome Measures

Primary Outcomes (1)

• time of Recovery

  the time from the end of surgery to awake of patient

  1day

Secondary Outcomes (4)

• Time records

  1 day

• dose of drugs

  1 day

• rate of respiratory suppression incidence

  1 day

• rate of Incidence of Treatment-Emergent Adverse Events

  1day

Other Outcomes (1)

• rate of Postoperative adverse reaction

  1 day

Study Arms (2)

Sufentanil group

EXPERIMENTAL

The dose of sufentanil group is 0.2μg/kg

Drug: Alfentanil

Alfentanil

EXPERIMENTAL

The dose of aifentanil group is 10μg/kg

Drug: Alfentanil

Interventions

Alfentanil DRUG

alfentanil 10ug/kg is used for anesthesia induction

Also known as: sufentanil

Alfentanil; Sufentanil group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead
• Xinxiang Central Hospital: collaborator

Study Sites (1)

Aijun Xu

Hubei, Wuhan, 430000, China

Location

MeSH Terms

Interventions

Alfentanil; Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• aijun xu, Dr

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clincal doctor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 14, 2024
• Study Start: May 20, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 28, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)