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Clinical Trials/EUCTR2013-004358-12-DK
EUCTR2013-004358-12-DK
Active, not recruiting
Phase 1

urse Administered Propofol Sedation vs. Midazolam- with Fentanyl-sedation for Flexible Bronchoscopy: A randomized, Single Blind, Controlled Study of Safety and Satisfaction. - Safety of NAPS vs standard sedation for fleksible broncoscopy.

Gentofte Hospital, Dep. of Medicine0 sitesNovember 22, 2013
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ConditionsSatisfaction and safety of propofol sedation during flexible bronchoscopy in patients undergoing endoscopic pulmonary investigation.MedDRA version: 17.1Level: LLTClassification code 10049683Term: Monitored anesthesia care sedationSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsPropofol B. BRAUNMidazolam HamelnFentanyl Hameln

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Satisfaction and safety of propofol sedation during flexible bronchoscopy in patients undergoing endoscopic pulmonary investigation.
Sponsor
Gentofte Hospital, Dep. of Medicine
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 22, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Gentofte Hospital, Dep. of Medicine

Eligibility Criteria

Inclusion Criteria

  • •1\. Elective flexible bronchoscopy.
  • •2\. Willing to be randomised
  • •3\. Provide written informed consent
  • •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 100
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 56

Exclusion Criteria

  • •1\. Allergy to contents administered
  • •2\. pregnant or nursing
  • •3\. \<18 years of age
  • •4\. Not able to complete questionnaire
  • •5\. Acute condition
  • •6\. severe COPD
  • •7\. \> ASA II
  • •8\. Sleep apnea
  • •9\. Risk of aspiration
  • •10\. Previously difficulty with anesthesia

Outcomes

Primary Outcomes

Not specified

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