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

NCT ID: NCT03789942

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2019-03-30

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.

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.

Conditions

Dental Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1. Local anaesthesia for oral surgery

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

Group Type: ACTIVE_COMPARATOR

Oral surgery

Intervention Type: PROCEDURE

Oral surgery procedures

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

Group Type: ACTIVE_COMPARATOR

Oral surgery

Intervention Type: PROCEDURE

Oral surgery procedures

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

Group Type: ACTIVE_COMPARATOR

Oral surgery

Intervention Type: PROCEDURE

Oral surgery procedures

Interventions

Oral surgery

Oral surgery procedures

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Luis Ortiz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ORTIZ CAMARERO

Role: PRINCIPAL_INVESTIGATOR

ASISTANT PROFESSOR

Locations

Clinica Luis Ortiz

Burgos, , Spain

Countries

Spain

Other Identifiers

ÉTICA-ULE-011-2016

Identifier Type: -

Identifier Source: org_study_id