Depth of Hypnosis and Postoperative Nausea and Vomiting During Xenon Anaesthesia

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Collaborator: Air Liquide Santé International
• Treatments: Anesthetics; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ondansetron; Sevoflurane; Xenon

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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