Conscious sedation for procedures in Dental and Minor Maxillofacial Surgery Unit: optimization of the dexmedetomidine dose (Dexdor®).

Phase 1

• Conditions: Sedation for procedures in Dental and Minor Maxillofacial Surgery Unit; MedDRA version: 17.0Level: PTClassification code 10054806Term: Maxillofacial operationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-002243-17-ES
• Lead Sponsor: Clínica Universidad de Navarra/Universidad de Navarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-09
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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

Study & Design

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