EUCTR2013-000290-73-ES
Active, not recruiting
Not Applicable
Randomized, double-blind, phase IV trial comparing the efficacy of two methods of sedation in patients scheduled for outpatient diagnostic-therapeutic colonoscopy.
FUNDACION C.V. HOSPITAL PROVINCIAL DE CASTELLO0 sitesApril 9, 2013
ConditionsSedation in patients (whose colonoscopy has been scheduled) with inhalatory sevorane versus standard intravenous sedation.MedDRA version: 16.0Level: LLTClassification code 10049124Term: Sedation during medical procedureSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sedation in patients (whose colonoscopy has been scheduled) with inhalatory sevorane versus standard intravenous sedation.
- Sponsor
- FUNDACION C.V. HOSPITAL PROVINCIAL DE CASTELLO
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patient scheduled to undergo outpatient diagnostic\-therapeutic colonoscopy who are referred from health centers in the province of Castellón.
- •(2\) Age between 18 and 65 years of age.
- •(3\) Informed consent signed prior to inclusion in the study.
- •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 278
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •(1\) Refusal of the patient to participate in the study.
- •(2\) Minors
- •(3\) Pregnancy or lactation
- •(4\) History of liver or kidney disease.
- •(5\) History of psychotropic substance abuse
- •(6\) Psychiatric illness
- •(7\) Difficulty in communication with the patient for reasons of language or intellectual deficit.
- •(8\) Bearded patients, due to difficulties in achieving a facial mask seal.
- •(9\) Difficulty in placing the facial mask (facial injuries or malformations).
- •(10\) Scheduled double exploration (gastroscopy and colonoscopy).
Outcomes
Primary Outcomes
Not specified
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