Modification of Blood Pressure Levels and Oxygen Saturation in Patients Undergoing Conscious Sedation
Condition: Dental Anxiety
Study type: Interventional

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.
    

Intervention name(s): Oral surgery
Intervention type(s): Procedure
Intervention description(s): Oral surgery procedures
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 90 patients 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.
Group 1, 30 patients treated by Oral Surgery procedures exclusively with Local Anesthesia.
Group 2, 30 patients treated by procedures of Oral Surgery with Local Anesthesia and Oral Sedation with Midazolam.
Group 3, 30 patients treated by Oral Surgery procedures with Local Anesthesia and Inhalation Sedation with a mixture of Nitrous Oxide / Oxygen.
Masking: None (Open Label)
Primary purpose: Treatment