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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014