Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02358057
Eligibility Criteria:
Inclusion Criteria:
Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:
* The insertion of a chest drain
* Abscess incision and drainage
* Closed reduction of a dislocated joint
Exclusion Criteria:
* Patients refusing to participate in the study (refusal to sign the consent form)
* Patients refusing sedation
* Patients unable to participate in the study (consent is impossible to obtain)
* Pregnant women
* The hypersensitivity to the active ingredient, dexmedetomidine hydrochloride.
* Patients with poor respiratory status determined by:
Respiratory rate \> 30 / min Oxygen saturation \<90%
* Patients with unfavorable hemodynamic status determined by :
A heart rate \> 120 / min A heart rate \< 50 / min Systolic blood pressure ≥ 180 mmHg or ≤100mmHg Diastolic blood pressure ≥ 110mmHg
* Patients with contraindication to the use of dexmedetomidine :
Advanced heart block (level 2 or 3) unless pacemaker Acute cerebrovascular disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02358057
Study Brief:
Protocol Section:
NCT02358057