Bispectral Index and Clinical Parameters Evaluation in Dental Procedures

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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%).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Francisco Groppo
• Collaborators: Faculty Sao Leopoldo Mandic Campinas; pontifical catholic university - Rio de Janeiro
• Treatments: Nitrous Oxide

Criteria

Inclusion Criteria:

• Any gender;

• Age from 18 to 60 years;

• Needing one or more specialized treatment, such as restorative dentistry, endodontics, implantology, or oral surgery.

Exclusion Criteria:

• 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.