Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia

Anesthesia, General Clinical Trial

— N20  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717574
• Other study ID #: 13800
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: June 13, 2012
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: June 2012
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anesthesia, General
• Deep Sedation

Intervention

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

Device:
• BIS Monitor
BIS Monitor electrodes placed on forehead
• Entropy Monitor
Entropy monitor electrodes placed to forehead

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		depth of anesthesia	Yes