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NCT Number: NCT03789942

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

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.

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Key information

Conditions

Dental Anxiety

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Luis Ortiz

Burgos, 09003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral surgery

Procedure

Oral surgery procedures

Primary outcomes

  1. 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

  2. Respiratory Rate change

    Time frame: From the beginning of the sedation until the end, assessed Up to one hour

    Respiratory Rate change

  3. 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

  4. 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

  5. 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

  6. Heart Rate change

    Time frame: From the beginning of the sedation until the end, assessed Up to one hour

    Heart Rate change

  7. Diastolic Blood Pressure change

    Time frame: From the beginning of the sedation until the end, assessed Up to one hour

    Diastolic Blood Pressure change

  8. Systolic blood pressure change

    Time frame: From the beginning of the sedation until the end, assessed Up to one hour

    Systolic blood pressure change

Sponsors and collaborators

Lead sponsor

Clinica Luis Ortiz

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2018
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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