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Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

NCT02246023 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2016-04-14

No results posted yet for this study

Summary

After randomization, the subjects undergo flexible bronchoscopy either with fractionated propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate, oxygen saturation, and oxygen requirement are measured continuously during the procedure and thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted continuously during and after the procedure.

Conditions

Interventions

DEVICE

Flexible bronchoscopy in moderate sedation

Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;

DEVICE

Oxygen saturation

Continuous measurement of oxygen saturation;

DEVICE

Blood pressure

Measurement of non-invasive blood pressure every 3 minutes

DEVICE

Propofol dosage

Report of dose adjustments und cumulative propofol dosage;

DEVICE

Recovery time after bronchoscopy

Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Daniel Franzen

    lead OTHER

Principal Investigators

  • Daniel Franzen, MD · Division of Pulmonology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246023 on ClinicalTrials.gov