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

NCT03789942 | Completed

• 1 other identifier: ÉTICA-ULE-011-2016
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (8)

• Partial Oxygen Saturation (SpO2) change

  Partial Oxygen Saturation (SpO2) change

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

• Respiratory Rate change

  Respiratory Rate change

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

• Forced Vital Capacity (FVC) change

  Forced Vital Capacity (FVC) change

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

• Forced Expiration Volume (FEV) change

  Forced Expiration Volume (FEV) change

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

• Maximum Expiratory Flow (PEF) change

  Maximum Expiratory Flow (PEF) change

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

• Heart Rate change

  Heart Rate change

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

• Diastolic Blood Pressure change

  Diastolic Blood Pressure change

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

• Systolic blood pressure change

  Systolic blood pressure change

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

Study Arms (3)

1. Local anaesthesia for oral surgery

ACTIVE COMPARATOR

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

Procedure: Oral surgery

2. Local anesthesia with Midazolam

ACTIVE COMPARATOR

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

3. Local anesthesia and sedation

ACTIVE COMPARATOR

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

Interventions

Oral surgery PROCEDURE

Oral surgery procedures

1. Local anaesthesia for oral surgery; 2. Local anesthesia with Midazolam; 3. Local anesthesia and sedation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Clinical conditions; ASA III, ASA IV and ASA V

Sponsors & Collaborators

• Clinica Luis Ortiz: lead

Study Sites (1)

Clinica Luis Ortiz

Burgos, 09003, Spain

Location

MeSH Terms

Interventions

Surgery, Oral

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• ORTIZ CAMARERO

  ASISTANT PROFESSOR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: December 31, 2018
• Study Start: February 15, 2019
• Primary Completion: March 20, 2019
• Study Completion: March 30, 2019
• Last Updated: April 2, 2019

Record last verified: 2018-12

Locations

ES (1)