EUCTR2014-002243-17-ES
Active, not recruiting
Phase 1
Conscious sedation for procedures in Dental and Minor Maxillofacial Surgery Unit: optimization of the dexmedetomidine dose (Dexdor®).
ConditionsSedation for procedures in Dental and Minor Maxillofacial Surgery UnitMedDRA version: 17.0Level: PTClassification code 10054806Term: Maxillofacial operationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsDexdor
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Sedation for procedures in Dental and Minor Maxillofacial Surgery Unit
- Sponsor
- Clínica Universidad de Navarra/Universidad de Navarra
- Enrollment
- 124
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Ability to provide informed consent and express his desire to meet all protocol requirements during the study.
- •2\.The patient should be able to meet with all requirements of the clinical trial.
- •3\.Above 18 years of age.
- •4\.A pregnancy test will be performed to women between 18 years old and menopause in order to rule out pregnancy unknown.
- •5\.The patient requires sedation to carry out one of the Dental procedures and Maxillofacial Surgery Unit: Complex wisdom 4 tooth extraction, Dental implants with or without bone stimulation.
- •6\.Individuals ASA I (healthy patient) or II (patient with a process mild systemic without limitations in daily activities.)
- •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 34
Exclusion Criteria
- •1\.Dexmedetomidine hypersensitivity
- •2\.HR \< 45bpm. Most individuals who participate in the study will be youth or individuals with hypertension controlled with drugs decrease HR \<60 bpm without any symptoms. So if the individual with HR\>45bpm does not shows sign of low cardiac output, he will be considered candidates for the study.
- •3\.Heart block grade 2\-3 without pacemaker
- •4\.Mean blood pressure \< 60mmHg.
- •5\.Severe stroke.
- •6\.Pregnancy and breastfeeding
Outcomes
Primary Outcomes
Not specified
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