Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Deep Sedation Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Sevoflurane group

Sevoflurane based general anesthesia

Group Type ACTIVE_COMPARATOR

Sevoflurane group

Intervention Type DRUG

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

Propofol group

Propofol based general anesthesia

Group Type ACTIVE_COMPARATOR

Propofol group

Intervention Type DRUG

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

Interventions

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Sevoflurane group

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

Intervention Type DRUG

Propofol group

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

Intervention Type DRUG

Other Intervention Names

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nitrous oxide nitrous oxide

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No