Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia

NCT00717574 | Completed Results DMC

• 1 other identifier: 13800
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Deep Sedation; Anesthesia, General

Keywords

depth of sedation; nitrous oxide; general anesthesia; anesthesia indices

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sevoflurane group

ACTIVE COMPARATOR

Sevoflurane based general anesthesia

Drug: Sevoflurane group

Propofol group

ACTIVE COMPARATOR

Propofol based general anesthesia

Drug: Propofol group

Interventions

Sevoflurane group DRUG

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

Also known as: nitrous oxide

Sevoflurane group

Propofol group DRUG

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

Also known as: nitrous oxide

Propofol group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18 to 55yrs
• ASA status less than and equal to 2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73152, United States

Location

Related 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. doi: 10.1093/bja/aeh036.

  PMID: 14722164 BACKGROUND

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Mehmet Ozcan, MD
• Organization: Department of Anesthesia. OUHSC

mehmet-ozcan@ouhsc.edu

405-271-4351

Study Officials

• Mehmet S Ozcan, M.D.

  Univeristy of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 17, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 31, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)