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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789942
Recruitment Status : Completed
First Posted : December 31, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Dental Anxiety Procedure: Oral surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
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
Official 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.
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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
Procedure: Oral surgery
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

Procedure: Oral surgery
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

Procedure: Oral surgery
Oral surgery procedures




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789942


Locations
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Spain
Clinica Luis Ortiz
Burgos, Spain, 09003
Sponsors and Collaborators
Clinica Luis Ortiz
Investigators
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Principal Investigator: ORTIZ CAMARERO ASISTANT PROFESSOR

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Responsible Party: Clinica Luis Ortiz
ClinicalTrials.gov Identifier: NCT03789942    
Other Study ID Numbers: ÉTICA-ULE-011-2016
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Midazolam
Nitrous Oxide
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Inhalation
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents