Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia (N20)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00717574
First received: July 9, 2008
Last updated: June 13, 2012
Last verified: June 2012

July 9, 2008
June 13, 2012
March 2008
October 2010   (final data collection date for primary outcome measure)
to demonstrate the effectiveness of two commonly used depth of anesthesia monitors (BIS & Entropy) on measuring the anesthetic effects of a commonly used anesthetic gas (nitrous oxide) [ Time Frame: depth of anesthesia ] [ Designated as safety issue: Yes ]
to demostrate the effectiveness of two commonly used depth of anesthesia monitors (BIS & Entropy) on measuring the anesthestic effects of a commonly used anesthetic gas (nitrous oxide) [ Time Frame: depth of anesthesia ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00717574 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia
Addition of Nitrous Oxide to a Sevoflurane or Propofol Based Anesthetic and Its Effects on Depth of Anesthesia Indices (N20)

The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant level of surgical stimulus

Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use. There are conflicting reports about the usefulness of these monitors when nitrous oxide is used as a part of the anesthetic regimen. While some studies demonstrate a decrease in BIS and Entropy, this study aims to investigate the effects of adding nitrous oxide to a sevoflurane or a propofol based anesthetic on BIS and Entropy indices.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Deep Sedation
  • Anesthesia, General
  • Drug: nitrous oxide
    Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
    Other Name: laughing gas
  • Device: BIS Monitor
    BIS Monitor electrodes placed on forehead
    Other Name: Anesthesia depth monitor
  • Device: Entropy Monitor
    Entropy monitor electrodes placed to forehead
    Other Name: Anesthesia depth monitor
  • Active Comparator: 1
    Sevoflurane based general anesthesia
    Interventions:
    • Drug: nitrous oxide
    • Device: BIS Monitor
    • Device: Entropy Monitor
  • Active Comparator: 2
    Propofol based general anesthesia
    Interventions:
    • Drug: nitrous oxide
    • Device: BIS Monitor
    • Device: Entropy Monitor
Anderson RE, Jakobsson JG. Entropy of EEG during anaesthetic induction: a comparative study with propofol or nitrous oxide as sole agent. Br J Anaesth. 2004 Feb;92(2):167-70.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 18 to 55yrs
  • ASA status less than and equal to 2

Exclusion Criteria:

  • Surgery on head and neck
  • ASA greater than 3
  • Contraindication to nitrous oxide
  • Pregnant women
  • History of dementia and stroke, or other organic brain disorder
  • Prisoner
  • Ear surgery
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717574
13800
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Mehmet S Ozcan, M.D. Univeristy of Illinois Chicago
University of Oklahoma
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP