Status:
COMPLETED
Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy
Lead Sponsor:
Infante, Javier Molina, M.D.
Conditions:
Procedural Sedation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Nonanesthesiologist administration of propofol for sedation is actually a field of growing interest for endoscopists, as demonstrated by recent American and European guidelines on this issue. Propofol...
Detailed Description
Justification of the study: Nonanesthesiologist administration of propofol is controversial owing to deep sedation concerns. One of the latest therapeutic innovations on this issue has been the devel...
Eligibility Criteria
Inclusion
- All patients undergoing elective outpatient colonoscopy
Exclusion
- Age less than 18 years
- Allergy to propofol, soybeans, eggs or midazolam
- Chronic intake of benzodiazepines
- History of colorectal surgery
- ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely
- Pregnancy
- Refusal, inability or unwillingness to give written consent
- Patients scheduled for advanced therapeutic colonoscopy or for more than one endoscopic procedure
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT01428882
Start Date
June 1 2011
End Date
December 1 2011
Last Update
May 25 2016
Active Locations (1)
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1
Hospital San Pedro de Alcantara
Cáceres, Caceres, Spain, 10003