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Completed

NCT Number: NCT06414018

Effect of Equivalent Dose of Alfentanil and Sufentanil in 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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aijun Xu

Hubei, Wuhan, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

alfentanil

Drug

alfentanil 10ug/kg is used for anesthesia induction

Other names: sufentanil

Primary outcomes

  1. time of Recovery

    Time frame: 1day

    the time from the end of surgery to awake of patient

Secondary outcomes

  1. Time records

    Time frame: 1 day

    Anesthesia time, induction time, surgical time, awakening time and recovery time

  2. dose of drugs

    Time frame: 1 day

    The total amount of sedative and analgesic drugs used.

  3. rate of respiratory suppression incidence

    Time frame: 1 day

    Respiratory frequency<8 times/min or SP02<90%

  4. rate of Incidence of Treatment-Emergent Adverse Events

    Time frame: 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

Other outcomes

  1. rate of Postoperative adverse reaction

    Time frame: 1 day

    Airway obstruction, hypoxemia, apnea, laryngeal spasm, bronchospasm, cough, postoperative nausea and vomiting, postoperative pain (VAS score), hypotension, bradycardia, dizziness

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • Xinxiang Central Hospital

Registry information

Official study title

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

Acronym: EOEDSAAIBT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 14, 2024
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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