Bispectral Index and Clinical Parameters Evaluation in Dental Procedures

NCT02671578 | Completed Phase 4

• 1 other identifier: BIS-01FOP
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND: The degree of consciousness during nitrous oxide use is still a matter of concern for both dentists and anesthesiologists. Investigators hypothesized that BIS levels do not vary according nitrous oxide concentration during minimum to moderate sedation in the dental treatment. METHODS: One hundred patients undergoing dental procedures demanding local anesthesia (1.8 mL of 2% lidocaine with 1:100.000 epinephrine) were enrolled in this study. Initial pain and anxiety were measured by 11-point numerical and anxiety visual scales, respectively. Systolic/diastolic arterial blood pressure, SpO2, heart and respiratory rates, and psychomotor ability (Trieger test) were assessed before, during and after dental treatment. Sedation levels were evaluated by both BIS and sedation analogic scale at the same intervals. The duration of treatment along with nitrous oxide concentration and side effects were observed. Kruskal-Wallis, Friedman and Mann-Whitney tests were used (alpha=5%).

Conditions

Anxiety; Pain

Keywords

nitrous oxide; conscious sedation; pain; anxiety

Outcome Measures

Primary Outcomes (1)

• BIS value

  Relative values continuously registered by the BIS device

  two hours

Secondary Outcomes (6)

• Pain

  two hours

• Anxiety

  two hours

• Blood Pressure

  two hours

• Heart rate

  two hours

• Respiratory Frequency (RF)

  two hours

Study Arms (1)

Nitrous oxide

EXPERIMENTAL

Nitrous oxide sedation

Drug: Nitrous Oxide

Interventions

Nitrous Oxide DRUG

The N2O/O2 equipment was composed by two flow meters with an anti-hypoxia system valve, 70% N2O maximum disposal and 30 L/min O2 valve to immediate oxygen dispensation. Masks were individually selected, being 100% O2 (6 L/min) dispensed until respiratory rate stabilization. N2O was incremented at 10% each 2 minutes (70% max, if necessary) until some of the following signals were noticed: silence, relax/comfort report, decreased eyelid movements, decreased spontaneous body movements, warm sensation, tingling sensation or numbness at feet, hands or oral region, and slightly euphoric sensation.

Also known as: Nitrous oxide / oxygen

Nitrous oxide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Any gender;
• Age from 18 to 60 years;
• Needing one or more specialized treatment, such as restorative dentistry, endodontics, implantology, or oral surgery.

You may not qualify if:

• Compulsive personality;
• Claustrophobia;
• Severe personal disorders;
• Chronic obstructive pulmonary diseases;
• Recent ear surgery history;
• Use of bleomycin during the last year;
• Use of CNS depressants;
• Use of analgesics or anti-inflammatory agents one week before the study;
• Former drug addicts;
• Pregnancy.

Sponsors & Collaborators

• Francisco Groppo: lead
• Faculty Sao Leopoldo Mandic Campinas: collaborator
• pontifical catholic university - Rio de Janeiro: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 2, 2016
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2008
• Last Updated: February 2, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share