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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
History of Changes
  Purpose

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


Condition Intervention
Deep Sedation
Anesthesia, General
 Drug: nitrous oxide
Device: BIS Monitor
Device: Entropy Monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Addition of Nitrous Oxide to a Sevoflurane or Propofol Based Anesthetic and Its Effects on Depth of Anesthesia Indices (N20)

Resource links provided by NLM:

MedlinePlus related topics: Gas
U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Sevoflurane based general anesthesia
 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: 2
Propofol based general anesthesia
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717574

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma, Oklahoma, United States, 73152
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Mehmet S Ozcan, M.D. Univeristy of Illinois Chicago
  More Information

Publications:

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00717574     History of Changes
Other Study ID Numbers: 13800
Study First Received: July 9, 2008
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
depth of sedation
nitrous oxide
general anesthesia
anesthesia indices

Additional relevant MeSH terms:
Anesthetics
Nitrous Oxide
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on May 21, 2013