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

Dental Anxiety Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789942
• Other study ID #: ÉTICA-ULE-011-2016
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: March 30, 2019

Study information

• Verified date: December 2018
• Source: Clinica Luis Ortiz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 30, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Anxiety

Intervention

Procedure:
• Oral surgery
Oral surgery procedures

Locations

Country	Name	City	State
Spain	Clinica Luis Ortiz	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Luis Ortiz

Country where clinical trial is conducted

Spain, 

Outcome

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