- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789942
Modification of Blood Pressure Levels and Oxygen Saturation in Patients Undergoing Conscious Sedation
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Burgos, Spain, 09003
- Clinica Luis Ortiz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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 |
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 |
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
Sponsor
Investigators
- Principal Investigator: ORTIZ CAMARERO, ASISTANT PROFESSOR
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Dental Anxiety
-
University of PaviaEnrolling by invitationDental Anxiety | Dental PhobiaItaly
-
Cairo UniversityUnknownAnxiety, Dental | Fear, Dental
-
St. Justine's HospitalRecruitingDental Anxiety | Dental Trauma | Dental Diseases | Dental PhobiaCanada
-
St. Justine's HospitalRecruitingDental Anxiety | Dental Trauma | Dental Diseases | Dental PhobiaCanada
-
National Taiwan University HospitalUnknownDental Anxiety | Dental Trauma | Dental DiseasesTaiwan
-
King Abdulaziz UniversityCompletedDental Anxiety | Dental FearSaudi Arabia
-
Cairo UniversityNot yet recruiting
-
Aisha Mohammed Hamziclinical professorNot yet recruiting
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruiting
-
Burdur Mehmet Akif Ersoy UniversityCompleted
Clinical Trials on Oral surgery
-
National Institute of Dental and Craniofacial Research...Completed
-
Maisonneuve-Rosemont HospitalUnknown
-
Karolinska InstitutetCompletedPeri-ImplantitisSweden
-
European Organisation for Research and Treatment...RecruitingOropharyngeal Cancer | Hypopharyngeal Squamous Cell Carcinoma | Supraglottic Squamous Cell CarcinomaSpain, Belgium, Switzerland, Italy, United Kingdom, Germany, France, Poland
-
Rigshospitalet, DenmarkActive, not recruitingQuality of Life | Pain | Oropharynx Cancer | Human Papilloma Virus | Swallowing Disorder | Saliva AlteredDenmark
-
University of Roma La SapienzaNot yet recruitingCancer of Colon | Nutrition Related Cancer
-
Lawson Health Research InstituteRecruitingHead and Neck Cancer | Oropharyngeal Squamous Cell CarcinomaCanada
-
Shin Kong Wu Ho-Su Memorial HospitalNational Yang Ming Chiao Tung UniversityRecruiting
-
Yokohama City UniversityASKA Pharmaceutical Co., Ltd.Active, not recruitingChronic Intestinal Pseudo-obstructionJapan
-
National Cheng-Kung University HospitalRecruitingSleep Apnea, ObstructiveTaiwan