N/A
N=32
Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia
Deep Sedation · Anesthesia, General
Bottom Line
View on ClinicalTrials.gov: NCT00717574 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE) — 36; 40; 32; 39 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sevoflurane group (Drug); Propofol group (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE) |
36; 40; 32; 39; 37; 43 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00717574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.