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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03901716
Enrollment
60
Registered
2019-04-03
Start date
2019-01-15
Completion date
2019-03-26
Last updated
2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopy, Conscious Sedation, Fentanyl, Narcotrend, Remifentanil, Sufentanil

Brief summary

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.

Interventions

DRUGSufentanil

Patients in Group S received sufentanil 0.1 mcg/kg.

DRUGFentanyl

Patients in Group F received fentanyl 1 mcg/kg.

DRUGRemifentanil

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

DRUGMidazolam

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

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* ASA grade I-II

Exclusion criteria

1. psychological disorders 2. SpO2\<90% in ambient air 3. hypersensitivity or allergy to anaesthetic drugs or benzodiazepine 4. severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy) 5. unstable haemodynamic status 6. habitual alcohol consumption 7. asthmatic patients

Design outcomes

Primary

MeasureTime frameDescription
Dosage of midazolamduring the procedureDosage of midazolam applied

Secondary

MeasureTime frameDescription
severity of coughduring the proceduretotal times of cough
patient's subjective tolerance30minutes after bronchoscopythe 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)
patient's global tolerance assessed by operator30minutes after bronchoscopythe global tolerance of patient to the procedure using a visual analogic scale (VAS: 1 mm: excellent tolerance, 100 mm very low tolerance)
rate of oxygen desaturationduring the procedureoxygen desaturation (SaO2 decrease\<90% for \>30 s)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026