Comparative study of the efficacy of clonidine and dexmetomidina in nasal endoscopic surgery anaesthesia

Active, not recruiting

• Conditions: asosinusal endoscopic surgery in patients with chronic sinusitis and/or nasal polyposis; MedDRA version: 18.0Level: PTClassification code 10009137Term: Chronic sinusitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 18.0Level: PTClassification code 10028755Term: Nasal polypectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2015-002102-37-ES
• Lead Sponsor: Fundació Parc Taulí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-31
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients of age >18 and < 65 years old
2. Patients with ASA criteria I, II or III
3. Patients who will undergo nasosinusal endoscopic surgery
because of chronic infectious sinusitis and/or nasal polyposis
4. Patients providing their 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 94
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have contraindications to the intended nasosinusalendoscopic surgery or to the anaesthesic treatment used in the routine clinical practice of this type of surgery.
2. Patients with impaired coagulation or who are treated with
antiaggregants or anticoagulants.
3. Patients with antecedents of coronary arteriopathy or heart rhytm
diseases (tachyarhythmias or blockages).
4. Patients that at the time of surgery show signs of hypovolemia, severe hypotension or signs of heart failure.
5. Patients with previous cerebro-vascular event.
6. Patients with chronic treatment with beta-adrenergic blocker agents, or calcium channel blocking agents that have not been withdrawn for a wash-out period equivalent to at least 7 half-lives of the drug before the surgery.
7. Patients for whom their caring physician considers that participation in the study may be clinically detrimental.

Study & Design

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