Sedation in patients (whose colonoscopy has been scheduled) with inhalatory sevorane versus standard intravenous sedation. MedDRA version: 16.0 Level: LLT Classification code 10049124 Term: Sedation during medical procedure System Organ Class: 100000004865
Conditions
Interventions
Trade Name: SEVORANE 1 mL volatile liquid for inhalation
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: Sevoflurane
CAS Number: 28523-86-6
Current Sponsor code: SEVORANE
Other des
Sponsors
FUNDACION C.V. HOSPITAL PROVINCIAL DE CASTELLON
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of sedation using a conventional intravenous technique versus another pure inhalation technique in patients scheduled for outpatient diagnostic and therapeutic colonoscopy. This effectiveness is to be determined by the quality of sedation as assessed by the endoscopist.;Secondary Objective: The specific objectives are: To compare the frequency of completed colonoscopies. To compare the frequency of patients with arterial desaturation, apnea or who require respiratory maneuvers to open the airway and ventilatory support. To compare the frequency of patients who present with movements which make exploration difficult. To compare the frequency of patients who develop cardiopulmonary complications. To compare the frequency of patients who present with over-sedation. To compare the frequency of hospital admissions. To compare the frequency of patients discharged after the first post-anesthetic assessment. To compare the extent of recovery 24 hours after exploration. To compare opinions and the satisfaction of patients.;Primary end point(s): The quality of sedation (during the colonoscopy) as assessed by the endoscopist.;Timepoint(s) of evaluation of this end point: The statistical analysis is set out when 278 patients has been sedated in order to perform a colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The statistical analysis is set out when 278 patients has been sedated in order to perform a colonoscopy.;Secondary end point(s): To compare the frequency of completed colonoscopies. To compare the frequency of patients with arterial desaturation, apnea or who require respiratory maneuvers to open the airway and ventilatory support. To compare the frequency of patients who present with movements which make exploration difficult. To compare the frequency of patients who develop cardiopulmonary complications. To compare the frequency of patients who present with over-sedation. To compare the frequency of hospital admissions. To compare the frequency of patients discharged after the first post-anesthetic assessment. To compare the extent of recovery 24 hours after exploration. To compare opinions and the satisfaction of patients. | — |
Countries
Spain
Contacts
Public ContactDAVID PERAL SANCHEZ
FUNDACION C.V. HOSPITAL PROVINCIAL DE CASTELLON
Outcome results
None listed