Randomized clinical trial to compare clonidine and propofol for the videoendoscopic examination with induced sleep

Phase 1

Conditions: Apnea hypopnea syndrome
MedDRA version: 19.0Level: LLTClassification code 10040976Term: Sleep apnea syndromeSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2015-003095-68-ES

Lead Sponsor: Fundació Parc Taulí

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Age < 18 or > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;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:<br>Site of upper airway collapse<br>OAA/s (Observational sedation scale) and BIS (Bispectral Index)<br>Correlation between BIS and EEG<br>Duration and results of the examination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Mean oxigen saturation<br>BP (Systolic and Dyastolic)<br>Degree of baseline subjective somnolence<br>Degree of reproducibility of the examination<br>Examination of the upper airway collapse areas<br>Characteristics of the snore<br>Duration of the examination (in minutes)<br>Maniouvres that modify the snore/apnea;Timepoint(s) of evaluation of this end point: During the endoscopic examination