COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Bispectral Index and Clinical Parameters Evaluation in Dental Procedures (BIS-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02671578
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
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

Show Show detailed description

Layout table for study information
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Layout table for additonal information
Responsible Party: Francisco Groppo, Professor, University of Campinas, Brazil 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
Additional relevant MeSH terms:
Layout table for MeSH terms
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents