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Modification of Blood Pressure Levels and Oxygen Saturation in Patients Undergoing Conscious Sedation

NCT03789942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-04-02

No results posted yet for this study

Summary

The objective is to compare the changes produced in cardiological and respiratory parameters in three groups of patients undergoing oral surgery. The first group was treated with local anesthesia, a second group with local anesthesia plus oral conscious sedation with midazolam, and a third subject under anesthesia local with inhalation sedation with nitrous oxide.

A total of 90 non-cooperative phobic adult patients belonging to the group of patients of the University Master in Oral Surgery, Implantology and Periodontics of the University of León will be included in this study, after their information and acceptance of verbal and written consent, separated into three groups without significant differences in age, sex, smoking habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.

They will be randomly divided into three groups of 30 patients each. They will be given a prior consent both of the procedures to be performed and of the sedation procedure to which they will be subjected, if that is the case, without knowing what dose they will be administered. In case of being sedated, they will be informed verbally of the details concerning the procedure.

Conditions

  • Dental Anxiety

Interventions

PROCEDURE

Oral surgery

Oral surgery procedures

Sponsors & Collaborators

  • Clinica Luis Ortiz

    lead OTHER

Principal Investigators

  • ORTIZ CAMARERO · ASISTANT PROFESSOR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2019-03-20
Completion
2019-03-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789942 on ClinicalTrials.gov