Randomized, double-blind, phase IV trial comparing the efficacy of two methods of sedation in patients scheduled for outpatient diagnostic-therapeutic colonoscopy.

• Conditions: Sedation 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: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-000290-73-ES
• Lead Sponsor: FUNDACION C.V. HOSPITAL PROVINCIAL DE CASTELLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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).
(11) Contraindication to any of the study drugs.
(12) Allergies to any of the components of the study drugs.
(13) Hemodynamic or respiratory instability or decompensation.
(14) Worsening of concomitant disease described in the basline visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified