Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia (N20)
| Tracking Information | |||||
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| First Received Date ICMJE | July 9, 2008 | ||||
| Last Updated Date | June 13, 2012 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00717574 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia | ||||
| Official Title ICMJE | Addition of Nitrous Oxide to a Sevoflurane or Propofol Based Anesthetic and Its Effects on Depth of Anesthesia Indices (N20) | ||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Intervention ICMJE |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 42 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00717574 | ||||
| Other Study ID Numbers ICMJE | 13800 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of Oklahoma | ||||
| Study Sponsor ICMJE | University of Oklahoma | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Oklahoma | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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