Modification of Blood Pressure Levels and Oxygen Saturation in Patients Undergoing Conscious Sedation
- Conditions
- Dental Anxiety
- Interventions
- Procedure: Oral surgery
- Registration Number
- NCT03789942
- Lead Sponsor
- Clinica Luis Ortiz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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).
- Clinical conditions; ASA III, ASA IV and ASA V
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. Local anaesthesia for oral surgery Oral surgery Administration of local anesthesia, 40mg.epinephrine once. Oral surgery procedures Suturing End of procedure 2. Local anesthesia with Midazolam Oral surgery Administration of 40mg. epinephrine once, and Oral Sedation with Midazolam 0,5 mgr per kilo once. Oral surgery procedures Suturing End of procedure 3. Local anesthesia and sedation Oral surgery 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
- Primary Outcome Measures
Name Time Method Systolic blood pressure change From the beginning of the sedation until the end, assessed Up to one hour Systolic blood pressure change
Respiratory Rate change From the beginning of the sedation until the end, assessed Up to one hour Respiratory Rate change
Heart Rate change From the beginning of the sedation until the end, assessed Up to one hour Heart Rate change
Forced Vital Capacity (FVC) change From the beginning of the sedation until the end, assessed Up to one hour Forced Vital Capacity (FVC) change
Maximum Expiratory Flow (PEF) change From the beginning of the sedation until the end, assessed Up to one hour Maximum Expiratory Flow (PEF) change
Partial Oxygen Saturation (SpO2) change From the beginning of the sedation until the end, assessed Up to one hour Partial Oxygen Saturation (SpO2) change
Forced Expiration Volume (FEV) change From the beginning of the sedation until the end, assessed Up to one hour Forced Expiration Volume (FEV) change
Diastolic Blood Pressure change From the beginning of the sedation until the end, assessed Up to one hour Diastolic Blood Pressure change
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinica Luis Ortiz
🇪🇸Burgos, Spain