Bispectral Index and Clinical Parameters Evaluation in Dental Procedures (BIS-01)
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|ClinicalTrials.gov Identifier: NCT02671578|
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
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%).
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Pain||Drug: Nitrous Oxide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bispectral Index and Clinical Parameters Evaluation in Different Dental Procedures With Nitrous Oxide and Oxygen Sedation|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2008|
Experimental: Nitrous oxide
Nitrous oxide sedation
Drug: Nitrous Oxide
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.
Other Name: Nitrous oxide / oxygen
- BIS value [ Time Frame: two hours ]Relative values continuously registered by the BIS device
- Pain [ Time Frame: two hours ]11-point numerical scale used to quantify the initial pain. The scale showed 0 as "no pain" and 10 as the "worst pain imaginable".
- Anxiety [ Time Frame: two hours ]Volunteers were asked to fill a facial image scale in order to determine the initial anxiety. This scale showed four levels: 0 corresponding to absolutely calm; 1 - slightly stressed; 2 - stressed; and 3 - extremely stressed.
- Blood Pressure [ Time Frame: two hours ]Measurement of blood pressure during two hours.
- Heart rate [ Time Frame: two hours ]Measurement of heart rate during two hours.
- Respiratory Frequency (RF) [ Time Frame: two hours ]Measurement of RF during two hours.
- Trieger test [ Time Frame: two hours ]Measurement of the lost points and time necessary for completion.