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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717574
First Posted: July 17, 2008
Last Update Posted: July 31, 2017
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.
Information provided by (Responsible Party):
University of Oklahoma
July 9, 2008
July 17, 2008
April 7, 2017
June 28, 2017
July 31, 2017
March 2008
October 2010   (Final data collection date for primary outcome measure)
The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE) [ Time Frame: From baseline to 20 minutes after the addition of 60% nitrous oxide ]

We planned this study to compare the effect of adding N2O on BIS and SE during an intravenous or an inhalation anesthetic. We hypothesized that neither BIS nor SE would decrease in response to the addition of N2O to a Propofol anesthetic. We also hypothesized that neither BIS nor SE would decrease in participants under Sevoflurane anesthesia if the inspired concentration of Sevoflurane were carefully and continuously adjusted to maintain a constant end-tidal concentration during the addition and discontinuation of N2O.

BIS (0-100) and SE (0-92) are unitless, ordinal indices of anesthetic depth. Both indices are decreased when the depth of anesthesia is increased.

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 ]
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Deep Sedation
  • Anesthesia, General
  • Drug: Sevoflurane group
    Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
    Other Name: nitrous oxide
  • Drug: Propofol group
    Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
    Other Name: nitrous oxide
  • Active Comparator: Sevoflurane group
    Sevoflurane based general anesthesia
    Intervention: Drug: Sevoflurane group
  • Active Comparator: Propofol group
    Propofol based general anesthesia
    Intervention: Drug: Propofol group
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
32
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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00717574
13800
Yes
Not Provided
Plan to Share IPD: No
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Mehmet S Ozcan, M.D. Univeristy of Illinois Chicago
University of Oklahoma
June 2017

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