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Clinical Trials/EUCTR2015-005274-38-SE
EUCTR2015-005274-38-SE
Active, not recruiting
Phase 1

Patient-controlled sedation with propofol versus combined sedation during bronchoscopy – a randomized controlled trial

Region Östergötland0 sites300 target enrollmentJanuary 21, 2016

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.

Registry
who.int
Start Date
January 21, 2016
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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