Reduces intravenous lidocaine the need for alfentanyl during colonoscopy under Procedural Sedation and Analgesia?
Phase 1
- Conditions
- patients with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-002210-46-NL
- Lead Sponsor
- niversity Medical Centre RadboudUMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 76
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
F.1.3.1 Number of subjects for this age range 76
Exclusion Criteria
Pregnancy.
Emergency colonoscopy.
Known allergies for study medication
Known rhythm disorders i.e. second or third degree AV block
BMI >35
Obstructive sleep apnea syndrome
Uncontrolled hypertension
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method