Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia (N20)

University of Oklahoma (OU)

Status: Completed

Conditions: Deep Sedation; Anesthesia, General

Treatments: Drug: Propofol group; Drug: Sevoflurane group

Study type: Interventional

Funder types: Other

Identifiers

NCT00717574

13800

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Sevoflurane group

Active Comparator group

Description:

Sevoflurane based general anesthesia

Treatment:

Drug: Sevoflurane group

Propofol group

Active Comparator group

Description:

Propofol based general anesthesia

Treatment:

Drug: Propofol group