EUCTR2016-002210-46-NL
Active, not recruiting
Phase 1
Study: Reduces intravenous lidocaine the need for alfentanyl during colonoscopy under Procedural Sedation and Analgesia?
niversity Medical Centre RadboudUMC0 sites76 target enrollmentJuly 28, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Medical Centre RadboudUMC
- Enrollment
- 76
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Colonoscopy performed under PSA
- •Age 18\-65 years
- •Inflammatory bowel disease: Crohn’s disease or ulcerative colitis
- •Informed consent
- •ASA classification 1 or 2
- •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 76
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Emergency colonoscopy.
- •Known allergies for study medication
- •Known rhythm disorders i.e. second or third degree AV block
- •Obstructive sleep apnea syndrome
- •Uncontrolled hypertension
Outcomes
Primary Outcomes
Not specified
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Unknown
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