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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dental Anxiety
- Sponsor
- Clinica Luis Ortiz
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Systolic blood pressure change
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Systolic blood pressure change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Systolic blood pressure change
Respiratory Rate change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Respiratory Rate change
Heart Rate change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Heart Rate change
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
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
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
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
Diastolic Blood Pressure change
Time Frame: From the beginning of the sedation until the end, assessed Up to one hour
Diastolic Blood Pressure change