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Depth of Hypnosis and Postoperative Nausea and Vomiting During Xenon Anaesthesia (XABP)

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ClinicalTrials.gov Identifier: NCT00793663
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : May 17, 2011
Air Liquide Santé International
Information provided by:
RWTH Aachen University

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 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.

Condition or disease Intervention/treatment Phase
Anaesthetics Gases, Xenon Anaesthetics Volatile, Sevoflurane Depth of Anaesthesia Postoperative Nausea Postoperative Vomiting Drug: Xenon Drug: Sevoflurane Drug: Dexamethasone Drug: NaCl Drug: Ondansetron Phase 4

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 is defined and will therefore be applied according to the investigated subject's age. Premedication will be performed with midazolam 7.5 mg orally 45 min before induction (standard dose and application form for adults as clinical practice of our department). Anesthesia will be induced in both groups with propofol 2 mg/kg i.v. and remifentanil 0.5 mcg/kg/min by infusion over 60 s. For tracheal intubation non-depolarizing neuromuscular blocking agents can be used (rocuronium 0.6 mg/kg). Both groups will receive remifentanil at a base rate of 0.2 mcg/kg/min. Xenon or sevoflurane can be titrated in the range from 0.8-1.1 MAC according to clinical needs based on the patient's hemodynamic, autonomic and somatic signs. Twenty minutes before the estimated cessation of all surgical procedures 0.05 mg kg-1 piritramide for post anesthetic pain management will be administered intravenously, as well as a short infusion of metamizole 15 mg kg-1.

    Depth of anesthesia (hypnosis) will be monitored with spontaneous EEG (BIS VISTA, Aspect Medical Systems, Newton, MA) and the mid latency auditory evoked potentials including a monitoring variable indicating the patients hypnotic state calculated from the MLAEP and the electroencephalogram, the composite A-Line ARX Index (cAAI) with the AEP Monitor/2 (Danmeter A/S, Odense, Denmark). Dosing will be conducted according to the current clinical standard without the monitoring, thus the anesthesia provider will be blinded towards both measurements.

  2. After induction of anesthesia patients will be randomized to a second factor, i.e. 4 mg dexamethasone or placebo for the prevention of PONV. To avoid potential imbalances, this will be achieved using a factorial design. The application of dexamethasone or placebo will be blinded to the investigator assessing postoperative nausea and vomiting.
  3. Patients who experience significant nausea will be randomized to receive either 4 mg ondansetron or placebo and the course of nausea will be assessed for > 32 min. Again, the application of ondansetron or placebo will be blinded to the investigator assessing postoperative nausea and vomiting. If the symptoms of postoperative nausea and vomiting persist for more than 32 min after treatment additional rescue treatment will be offered. Of note, all patients are able to receive further rescue treatment at any time point of the study on demand.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 1) The Effect of Xenon and Sevoflurane on Hypnosis Monitors. 2) Prevention of Postoperative Nausea and Vomiting. 3) Rescue Treatment of Established Postoperative Nausea and Vomiting. Sevoflurane.
Study Start Date : November 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
The effect of xenon as an anaesthetic on the depth of hypnosis.
Drug: Xenon
Inhalational gas; maximum dose allowed: 70 % Xenon; the duration of the treatment will be defined through anesthesia-time.
Other Name: LENOXe

Active Comparator: 2
The effect of sevoflurane as an anesthetic on the depth of hypnosis
Drug: Sevoflurane
Inhalation gas; age adapted MAC-values; the duration of the treatment will be defined through anesthesia-time
Other Name: Sevorane

Experimental: 3
Dexamethasone as prevention of postoperative nausea and vomiting after xenon or sevoflurane anesthesia
Drug: Dexamethasone
Intravenous use, 4 mg, single shot
Other Name: Fortecortin Inject

Placebo Comparator: 4 Drug: NaCl
Intravenous use; single shot

Experimental: 5
Ondansetron, to determine the onset-time of ondansetron when used as rescue medication for postoperative nausea and vomiting
Drug: Ondansetron
Intravenous use; 4 mg; single shot
Other Name: Zofran

Placebo Comparator: 6 Drug: NaCl
Intravenous use; single shot

Primary Outcome Measures :
  1. The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure. [ Time Frame: During anaesthesia ]
  2. Postoperative nausea as assessed by a verbal rating scale (VRS) ranging between 0 and 10. [ Time Frame: After anesthesia at 5, 10, 15, 30, 45, 60, and 90 min. At 2, 6 and 24 h after anesthesia the maximum nausea will be rated for the 30-120 min, 2-6 h, and 6-24 h interval. ]
  3. Reduction of VRS nausea immediately at 2, 5, 7.5, 10, 15, 20 and 30 min after rescue treatment administration. [ Time Frame: Maximum nausea will be rated at 2, 6 and 24 hours after treatment for the 30-120 min, 2-6 h and 6-24 h interval. ]

Secondary Outcome Measures :
  1. Heart rate and blood pressure [ Time Frame: During anesthesia ]
  2. Observer´s assessment of alertness and sedation scales [ Time Frame: Recovery from anesthesia ]
  3. Sensitivity and specificity characteristics for both the BIS and the cAAI. [ Time Frame: During anesthesia ]
  4. Awareness after anesthesia assessed by the Brice questionnaire at 2 and 24 hours after anesthesia. [ Time Frame: 24 hours after anaesthesia ]
  5. Occurrence of postoperative vomiting and the respective time-points will be recorded. Postoperative vomiting is defined as vomiting or retching. [ Time Frame: 24 hours postoperative ]
  6. Usage of rescue medication, time and dosage [ Time Frame: 24 hours postoperative ]
  7. Time to discharge from post anesthetic care unit (Aldrete Score ≥ 9 equals the hypothetic discharge time from post anesthetic care unit) [ Time Frame: Time in the post anesthetic care unit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793663

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RWTH Aachen University; Department of Anesthesiology
Aachen, Germany, D-52074
Sponsors and Collaborators
RWTH Aachen University
Air Liquide Santé International
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Study Chair: Rolf Rossaint, MD RWTH University Aachen; Department of Anesthesiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Mark Coburn, Principal Investigator, RWTH Aachen University; Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00793663    
Other Study ID Numbers: ALS-8-08-A-401
Protocol version:
Version V3; Date: 20.10.2008
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: May 2011
Keywords provided by RWTH Aachen University:
Postoperative Nausea and vomiting
Depth of anaesthesia
Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Dermatologic Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists