Status:
COMPLETED
Depth of Hypnosis and Postoperative Nausea and Vomiting During Xenon Anaesthesia
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
Air Liquide Santé International
Conditions:
Anaesthetics Gases, Xenon
Anaesthetics Volatile, Sevoflurane
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 sy...
Detailed Description
1. Patients included into the trial will randomly be allocated to either 0.8-1.1 minimum alveolar concentration (MAC) xenon in 30 % oxygen or 0.8-1.1 MAC sevoflurane (age adapted)/30 % oxygen. The MAC...
Eligibility Criteria
Inclusion
- patients ≥ 18 \< 75 years
- ASA physical status I-II
- planned duration of anesthesia ≥ 60 minutes
- Apfel score ≥ 2-3
- elective (laparoscopic) surgery (abdominal, gynecological)
- women: with a highly effective contraception, defined as methods with a pearl index \< 1 (i.e. hormonal contraceptives, IUD)
Exclusion
- history of hypersensitivity to any used drugs or additive components used for preparation and stabilization of the named drugs in this trial
- history or reasonable suspicion of malignant hyperthermia and/or degenerative neuromuscular disease, in the subject observed or blood relatives
- history of liver function disorders, leucocytosis and unclear fever after usage of halogenated anesthetics.
- any indisposition that may be aggravated by the use of the drugs investigated:
- liver and/or kidney function disorders
- severe acute or chronic infectious disease (i.e. viral, bacterial, fungal)
- elevated intracranial pressure
- history of gastrointestinal ulcer(s) or inflammatory bowel disease
- severe metabolic disorders
- hematoporphyria
- glaucoma
- hearing disorders
- any disease including air-filled closed cavities, such as pneumothorax, ileus
- pregnancy and lactation period
- subjects under the age of 18 years
- ambulatory surgery
- any disease that is associated with the requirement of a high oxygen yield and/or
- risk of high oxygen consumption:
- severe lung and/or airway disease
- coronary heart disease and/or seriously impaired cardiac function
- severe psychiatric disorder
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00793663
Start Date
November 1 2008
End Date
April 1 2011
Last Update
May 17 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
RWTH Aachen University; Department of Anesthesiology
Aachen, Germany, D-52074