Depth of Hypnosis and Postoperative Nausea and Vomiting During Xenon Anaesthesia

Summary

The purpose of this study is ad 1) to measure the depth of hypnosis as assessed by BIS and cAAI during an average general anesthesia with xenon or sevoflurane and to establish a reliable monitoring system for measuring and documenting the actual depth of hypnosis for the volatile anesthetics investigated. Ad 2) the question is to be answered whether 4 mg dexamethasone i.v. is an effective prophylactic treatment against postoperative nausea and vomiting in case of xenon or sevoflurane anesthesia. Ad 3) it serves to gain evidence about the (non-)effectiveness and kinetics of ondansetron as antiemetic remedy after xenon or sevoflurane anesthesia.

Conditions

• Anaesthetics Gases, Xenon
• Anaesthetics Volatile, Sevoflurane
• Depth of Anaesthesia
• Postoperative Nausea
• Postoperative Vomiting

Interventions

DRUG

Xenon

Inhalational gas; maximum dose allowed: 70 % Xenon; the duration of the treatment will be defined through anesthesia-time.

DRUG

Sevoflurane

Inhalation gas; age adapted MAC-values; the duration of the treatment will be defined through anesthesia-time

DRUG

Dexamethasone

Intravenous use, 4 mg, single shot

DRUG

NaCl

Intravenous use; single shot

DRUG

Ondansetron

Intravenous use; 4 mg; single shot

DRUG

NaCl

Intravenous use; single shot

Sponsors & Collaborators

• Air Liquide Santé International

  collaborator INDUSTRY

• RWTH Aachen University

  lead OTHER

Principal Investigators

• Rolf Rossaint, MD · RWTH University Aachen; Department of Anesthesiology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2011-04-30

Completion

2011-04-30

Countries

• Germany

Study Locations