Effect of two different forms of propofol administration on sedation during bronchoscopy

Impact of target-controlled infusion (TCI) of propofol on state- and response-entropy and sedation depth during flexible bronchoscopy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN56531234

Enrollment

Registered

2020-12-04

Start date

2014-06-01

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Sedation during flexible bronchoscopy Not Applicable

Interventions

Due to the observational design of the study no specific intervention related to the study is performed. Patients scheduled for diagnostic or interventional bronchoscopy are non-random

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled for diagnostic or interventional bronchoscopy with an estimated duration >10 min

Exclusion criteria

Exclusion criteria: 1. Age 125 bpm 9. Tachycardic arrhythmias 10. Acute coronary syndrome 11. Severe heart failure 12. Septic shock 13. Severe hepatic impairment 14. Systolic blood pressure 40 kg/m²

Design outcomes

Primary

Measure	Time frame
1. Level of sedation measured with Response and State Entropy (RE+SE), expressed as mean ± SEM representing the baseline starting points, the induction period until loss of consciousness (LOC), the LOC itself as a timepoint, and the procedure until the end of bronchoscopy 2. Sedation quality measured using a questionnaire to be completed by proceduralists and assisting nurses right after examination. Sedation quality could be rated using a grading system from Grade 1 = “Patient was very calm, excellent working conditions” up to Grade 6 "Patient was uneasy, not good working conditions". Expressed as numbers n and percentage 3. Total amount of propofol, and duration until LOC and duration of the procedure, expressed as mean ± SEM, measured using a timer function within the recording software, starting right before the sedation starts and ending 10 min after bronchoscopy ends	—

Measure

Time frame

1. Level of sedation measured with Response and State Entropy (RE+SE), expressed as mean ± SEM representing the baseline starting points, the induction period until loss of consciousness (LOC), the LOC itself as a timepoint, and the procedure until the end of bronchoscopy 2. Sedation quality measured using a questionnaire to be completed by proceduralists and assisting nurses right after examination. Sedation quality could be rated using a grading system from Grade 1 = “Patient was very calm, excellent working conditions” up to Grade 6 "Patient was uneasy, not good working conditions". Expressed as numbers n and percentage 3. Total amount of propofol, and duration until LOC and duration of the procedure, expressed as mean ± SEM, measured using a timer function within the recording software, starting right before the sedation starts and ending 10 min after bronchoscopy ends

—

Secondary

Measure	Time frame
Adverse effects of the sedation protocol, i.e. heart rate >125 bpm and 120% of baseline, SpO2 10 sec and respiratory rate <8/min, expressed as number (n) and percentage (%), measured using a monitoring device and software recording every vital sign in real-time every second for HR and SpO2 and every 2.5 min for respiratory rate during the whole procedure	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026