EUCTR2015-005274-38-SE
Active, not recruiting
Phase 1
Patient-controlled sedation with propofol versus combined sedation during bronchoscopy – a randomized controlled trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Region Östergötland
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patient (\=18 years)
- •Planned bronchoscopic procedure with sedation in an outpatient setting
- •The patient have after receiving information about the study given their signed informed consent to participate.
- •Women of childbearing potential only if use of highly effective contraceptive.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 270
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 30
Exclusion Criteria
- •Known pregnancy or planning to be pregnant
- •Known/suspected allergy or contraindication to any medication within the study.
- •Functional disability in both hands which affect the possibility to operate the PCS device.
- •Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.
Outcomes
Primary Outcomes
Not specified
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