Apnea hypopnea syndrome MedDRA version: 19.0 Level: LLT Classification code 10040976 Term: Sleep apnea syndrome System Organ Class: 100000004855
Conditions
Interventions
Product Name: clonidine
Product Code: C02AC01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLONIDINE
CAS Number: 4205-90-7
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
Fundació Parc Taulí
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients between 18 and 65 years old - Patients with ASA (American Society of Anesthesiologists) criteria I or II - Patients with Apnea-Hypopnea sleep syndrome of moderate or severe intensity, with no morbid obesity and who do not tolerate CPAP (continuous positive airway pressure) Patients with Apnea-Hypopnea syndrome in which the surgical treatment with mandibular advanced device is indicated - Patients with Apnea-hypopnea sleep syndrome who have not responded to surgical treatment - Informed consent 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Age 65 years old Alergic to propofol (ie soya bean or egg) or to clonidine High surgical risk (ASA III or higher) Severe cardiaack blockage (grade 2-3) without a pace maker Non controlled hypotension Severe cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the sleep pattern induced by clonidine and propofol in terms of proportion of patients who reach the N2 sleep phase without progressing to other phases during the examination;Secondary Objective: To compare during the examination and by direct observation or blind evaluation: Site of upper airway collapse OAA/s (Observational sedation scale) and BIS (Bispectral Index) Correlation between BIS and EEG Duration and results of the examination;Primary end point(s): Proportion of patients that reach sleep phase N2 without progressing to deeper sleep phases, assessed by means of hypnogram;Timepoint(s) of evaluation of this end point: During the endoscopic examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean oxigen saturation BP (Systolic and Dyastolic) Degree of baseline subjective somnolence Degree of reproducibility of the examination Examination of the upper airway collapse areas Characteristics of the snore Duration of the examination (in minutes) Maniouvres that modify the snore/apnea;Timepoint(s) of evaluation of this end point: During the endoscopic examination | — |
Countries
Spain
Contacts
Public ContactOficina de Recerca
Hospital Universitari Parc Taulí
Outcome results
None listed