AzTrials
AzTrials

AnxietyPhase 4BIS-01NCT02671578

Bispectral Index and Clinical Parameters Evaluation in Dental Procedures

A Phase 4 study testing Nitrous Oxide in people with Anxiety and Pain, run by Francisco Groppo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Pain
What is being tested?
Nitrous Oxide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Nov 2006to Nov 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Compulsive personality;
  • Claustrophobia;
  • Severe personal disorders;
  • Chronic obstructive pulmonary diseases;
  • Recent ear surgery history;
  • Use of bleomycin during the last year;
Show all 10Show fewer
  • Use of CNS depressants;
  • Use of analgesics or anti-inflammatory agents one week before the study;
  • Former drug addicts;
  • Pregnancy.

About this study

Official title: Bispectral Index and Clinical Parameters Evaluation in Different Dental Procedures With Nitrous Oxide and Oxygen Sedation

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%).

Read the detailed description

One-hundred ASA I / II volunteers of both genders were selected in different dental speciality clinics (restorative dentistry, endodontics, implantology, and oral surgery) of Dental Institute of Pontifical Catholic University of Rio de Janeiro PUC-Rio).

After anamnesis and obtaining written informed consent, all volunteers were asked to fill an 11-point numerical scale in order to quantify the initial pain. The scale showed 0 as "no pain" and 10 as the "worst pain imaginable". In addition, volunteers were also 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.

The volunteers were positioned in the dental chair and instructed to fill a Trieger test (psychomotor evaluation) during the following periods: 1) before sedation; 2) during the sedation (10 minutes after respiratory stabilization with N2O/O2); and 3) 10 minutes after the end of sedation. The number of wrong connected points (precision) and the time required to fill all points were used to estimate psychomotor ability.

A pulse oxymeter was placed in the volunteers' thumb and an electronic sphygmomanometer was positioned in the forearm in order to evaluate oxygen saturation (SpO2), systolic and diastolic pressures, and hearth rate during the same moments of the Trieger test. Respiratory rate was evaluated at same moments, by direct observation of thoracic movements.

The electrodes of BIS monitor were placed and the values were obtained at same operatory periods previously described, despite the continuous BIS monitoring. After BIS-signal stabilization, the dental procedure and the sedation with N2O/O2 were explained to the volunteer. Two previously calibrated operators installed BIS electrodes, applied the Trieger test and sedated all subjects. A third operator performed the dental treatments.

Five minutes after reaching ideal sedation level, the anesthetic solution (1.8 mL of 2% lidocaine with 1:100.000 epinephrine) was injected. Right after the end of clinical procedure, 100% O2 were provided during 5 minutes and a new Trieger test was filled out. The volunteer was dismissed if this last Trieger test was compatible with the first one. At this moment, they were also asked about discomfort or complications. The duration and type of dental procedure were also registered.

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. The dental procedure started after 5 min from the ideal sedation achievement.

The sedation level was scored by using the five-points Observer's Assessment of Alertness/Sedation (OAA/S) scale, previously described elsewhere. In addition, BIS was used to monitoring brain cortical activity at 0.5 to 30 Hz frequency bandwidth, checking impedance before every reading. Impedance remained below 800 ohms. Zipprep-type electrodes were placed according to manufacturer instructions. Fp1-Fpz was monitored in channel 1, Fp2-Fpz in channel 2 and the ground reference was placed on the pre-auricular region. BIS and both BIS channel waves were recorded from successive 2 seconds periods 13 and updated at every 5 seconds. The automatic artifact detection and rejection system of the BIS monitor were used. Baseline levels were obtained before sedation.

Results were submitted to Kruskal-Wallis' (Dunn), Friedman's, Mann-Whitney's and Spearman's correlation tests. The significance level was set at 5%. The analysis was performed by using BioEstat 5.0.

Conditions
Anxiety, Pain
Being tested
Nitrous Oxide
Keywords
nitrous oxide, conscious sedation, pain, anxiety
Medical subject headings
Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitrous OxideDrug

    Also called Nitrous oxide / oxygen

    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.

Study groups in NCT02671578
Study groupRoleWhat they receive
Nitrous oxideExperimentalNitrous oxide sedation
Receives: Drug: Nitrous Oxide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BIS value

    Relative values continuously registered by the BIS device

    Measured: two hours

Secondary outcomes (6)
  1. Pain

    11-point numerical scale used to quantify the initial pain. The scale showed 0 as "no pain" and 10 as the "worst pain imaginable".

    Measured: two hours

  2. Anxiety

    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.

    Measured: two hours

  3. Blood Pressure

    Measurement of blood pressure during two hours.

    Measured: two hours

  4. Heart rate

    Measurement of heart rate during two hours.

    Measured: two hours

  5. Respiratory Frequency (RF)

    Measurement of RF during two hours.

    Measured: two hours

  6. Trieger test

    Measurement of the lost points and time necessary for completion.

    Measured: two hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2016 (estimated)
  2. Study startNov 2006
  3. Primary completionNov 2007
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02671578
Sponsor's protocol ID
BIS-01FOP
Acronym
BIS-01
Status last verified
Jan 2016
First submitted
20 Jan 2016
Last updated
2 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nitrous Oxide in people with Anxiety and Pain, run by Francisco Groppo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BIS value (time frame: two hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in