NCT00717574|CompletedResultsDMC
Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia
N20
Addition of Nitrous Oxide to a Sevoflurane or Propofol Based Anesthetic and Its Effects on Depth of Anesthesia Indices (N20)
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Sponsor study identifier
interventional
32
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Actual (reported)Study Completion
October 2010
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 9, 2008
Actual (reported)July 17, 2008
Actual (reported)October 2010
Actual (reported)October 2010
Actual (reported)June 28, 2017
Actual (reported)The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)
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.
From baseline to 20 minutes after the addition of 60% nitrous oxide
Sevoflurane based general anesthesia
Propofol based general anesthesia
Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73152, United States
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. doi: 10.1093/bja/aeh036.
1. We did not measure the blood concentrations of Sevoflurane. 2. Variety of surgical procedures might have lead to different levels of noxious stimuli. 3. Noxious stimuli and administration of opioids may affect EEG-derived indices.
Mehmet S Ozcan, M.D.
Univeristy of Illinois Chicago
32 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2008
First Posted
July 17, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Heart Rate Variability Under Propofol and Sevoflurane
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Primary Completion
October 2010
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
July 31, 2017
Results First Posted
June 28, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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