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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
Sponsor:
Collaborators:
Faculty Sao Leopoldo Mandic Campinas
pontifical catholic university - Rio de Janeiro
Information provided by (Responsible Party):
Francisco Groppo, University of Campinas, Brazil

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%).


Condition or disease Intervention/treatment Phase
Anxiety Pain Drug: Nitrous Oxide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. BIS value [ Time Frame: two hours ]
    Relative values continuously registered by the BIS device


Secondary Outcome Measures :
  1. 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".

  2. 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.

  3. Blood Pressure [ Time Frame: two hours ]
    Measurement of blood pressure during two hours.

  4. Heart rate [ Time Frame: two hours ]
    Measurement of heart rate during two hours.

  5. Respiratory Frequency (RF) [ Time Frame: two hours ]
    Measurement of RF during two hours.

  6. Trieger test [ Time Frame: two hours ]
    Measurement of the lost points and time necessary for completion.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Francisco Groppo, Professor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02671578    
Other Study ID Numbers: BIS-01FOP
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francisco Groppo, University of Campinas, Brazil:
nitrous oxide
conscious sedation
pain
anxiety
Additional relevant MeSH terms:
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Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents