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

Clinica Luis Ortiz

Status: Completed

Conditions: Dental Anxiety

Treatments: Procedure: Oral surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03789942

ÉTICA-ULE-011-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

1. Local anaesthesia for oral surgery

Active Comparator group

Description:

Administration of local anesthesia, 40mg.epinephrine once. Oral surgery procedures Suturing End of procedure

Treatment:

Procedure: Oral surgery

2. Local anesthesia with Midazolam

Active Comparator group

Description:

Administration of 40mg. epinephrine once, and Oral Sedation with Midazolam 0,5 mgr per kilo once. Oral surgery procedures Suturing End of procedure

Treatment:

Procedure: Oral surgery

3. Local anesthesia and sedation

Active Comparator group

Description:

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

Treatment:

Procedure: Oral surgery