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

March 30, 2019 updated by: Clinica Luis Ortiz

Comparative Clinical Study of Cardiac and Respiratory Modifications Produced in Patients Undergoing Oral Surgery Through Local Anesthesia, Local Anesthesia and Oral Sedation With Midazolam, and Local Anesthesia Associated to Nitrous Oxide.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 90 non-cooperative phobic adult patients 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.

Initially, a complete health questionnaire will be filled out in all patients, and Partial Oxygen Saturation (SpO2), Respiratory Rate, Respiratory Volume in the form of Forced Vital Capacity (FVC), and also Forced Expiration Volume will be recorded as respiratory records (FEV) and Maximum Expiratory Flow (PEF), and as cardiac registers the Heart Rate, and the Systolic and Diastolic Blood Pressure before starting the procedure, records that will be repeated every 5 minutes during and until the end of it. The parameters will be recorded every 5 minutes, except for the parameters VFC, FEV1 and PEF that will be recorded exclusively at the beginning and at the end of the procedure.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Burgos, Spain, 09003
        • Clinica Luis Ortiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical Diagnosis of phobic patients
  • Not having contraindications to be anesthetized or sedated, and
  • Present an acceptable state of health (ASA I and ASA II).

Exclusion Criteria:

  • Clinical conditions; ASA III, ASA IV and ASA V

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1. Local anaesthesia for oral surgery
Administration of local anesthesia, 40mg.epinephrine once. Oral surgery procedures Suturing End of procedure
Procedure: Oral surgery
Oral surgery procedures
Active Comparator: 2. Local anesthesia with Midazolam

Administration of 40mg. epinephrine once, and Oral Sedation with Midazolam 0,5 mgr per kilo once.

Oral surgery procedures Suturing End of procedure
Procedure: Oral surgery
Oral surgery procedures
Active Comparator: 3. Local anesthesia and sedation

Administration of 40mg. epinephrine once, and Inhalation Sedation by Nitrous Oxide / Oxygen.

Nitrous oxide sedation Oral surgery procedures Suturing End of procedure Reduce nitrous oxide concentration
Procedure: Oral surgery
Oral surgery procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial Oxygen Saturation (SpO2) change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Partial Oxygen Saturation (SpO2) change
From the beginning of the sedation until the end, assessed Up to one hour
Respiratory Rate change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Respiratory Rate change
From the beginning of the sedation until the end, assessed Up to one hour
Forced Vital Capacity (FVC) change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Forced Vital Capacity (FVC) change
From the beginning of the sedation until the end, assessed Up to one hour
Forced Expiration Volume (FEV) change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Forced Expiration Volume (FEV) change
From the beginning of the sedation until the end, assessed Up to one hour
Maximum Expiratory Flow (PEF) change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Maximum Expiratory Flow (PEF) change
From the beginning of the sedation until the end, assessed Up to one hour
Heart Rate change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Heart Rate change
From the beginning of the sedation until the end, assessed Up to one hour
Diastolic Blood Pressure change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Diastolic Blood Pressure change
From the beginning of the sedation until the end, assessed Up to one hour
Systolic blood pressure change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Systolic blood pressure change
From the beginning of the sedation until the end, assessed Up to one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Luis Ortiz

Investigators

  • Principal Investigator: ORTIZ CAMARERO, ASISTANT PROFESSOR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2019

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

July 14, 2018

First Submitted That Met QC Criteria

December 27, 2018

First Posted (Actual)

December 31, 2018

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 30, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ÉTICA-ULE-011-2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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