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Completed

NCT Number: NCT00717574

Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia

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

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Key information

Conditions

Deep Sedation Anesthesia, General

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane group

Drug

Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.

Other names: nitrous oxide

Propofol group

Drug

Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.

Other names: nitrous oxide

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Addition of Nitrous Oxide to a Sevoflurane or Propofol Based Anesthetic and Its Effects on Depth of Anesthesia Indices (N20)

Acronym: N20

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2008
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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