Skip to main content
OpenTrials
Completed

NCT Number: NCT03901716

Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation

The best opioid for bronchoscopy is still unclear.This randomized double-blind prospective study was conducted on a total of 60 patients who were randomly allocated into 3 groups: Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml. Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Adverse events, patient tolerance and physician satisfaction were analized.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sufentanil Bronchoscopy Conscious Sedation Fentanyl Narcotrend Remifentanil

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA grade I-II

Exclusion criteria

  • psychological disorders
  • SpO2<90% in ambient air
  • hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
  • severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
  • unstable haemodynamic status
  • habitual alcohol consumption
  • asthmatic patients

Treatment and study plan

Sufentanil

Drug

Patients in Group S received sufentanil 0.1 mcg/kg.

Fentanyl

Drug

Patients in Group F received fentanyl 1 mcg/kg.

Remifentanil

Drug

Patients in Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml.

midazolam

Drug

Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).

Primary outcomes

  1. Dosage of midazolam

    Time frame: during the procedure

    Dosage of midazolam applied

Secondary outcomes

  1. severity of cough

    Time frame: during the procedure

    total times of cough

  2. patient's subjective tolerance

    Time frame: 30minutes after bronchoscopy

    the intensity of four key symptoms during bronchoscopy (pain, nausea, breathlessness and cough) and memory using a visual analogic scale (VAS: 1 mm: excellent tolerance, 100 mm very low tolerance)

  3. patient's global tolerance assessed by operator

    Time frame: 30minutes after bronchoscopy

    the global tolerance of patient to the procedure using a visual analogic scale (VAS: 1 mm: excellent tolerance, 100 mm very low tolerance)

  4. rate of oxygen desaturation

    Time frame: during the procedure

    oxygen desaturation (SaO2 decrease<90% for >30 s)

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation: A Randomized Double-blind Prospective Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2019
Registry last updated
Apr 3, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.