Depth of Hypnosis and Postoperative Nausea and Vomiting During Xenon Anaesthesia
Information source: RWTH Aachen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anaesthetics Gases, Xenon; Anaesthetics Volatile, Sevoflurane; Depth of Anaesthesia; Postoperative Nausea; Postoperative Vomiting
Intervention: Xenon (Drug); Sevoflurane (Drug); Dexamethasone (Drug); NaCl (Drug); Ondansetron (Drug); NaCl (Drug)
Phase: Phase 4
Sponsored by: RWTH Aachen University
Official(s) and/or principal investigator(s):
Rolf Rossaint, MD, Study Chair, Affiliation: RWTH University Aachen; Department of Anesthesiology
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
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure.
Postoperative nausea as assessed by a verbal rating scale (VRS) ranging between 0 and 10.
Reduction of VRS nausea immediately at 2, 5, 7.5, 10, 15, 20 and 30 min after rescue treatment administration.
Heart rate and blood pressure
Observer´s assessment of alertness and sedation scales
Sensitivity and specificity characteristics for both the BIS and the cAAI.
Awareness after anesthesia assessed by the Brice questionnaire at 2 and 24 hours after anesthesia.
Occurrence of postoperative vomiting and the respective time-points will be recorded. Postoperative vomiting is defined as vomiting or retching.
Usage of rescue medication, time and dosage
Time to discharge from post anesthetic care unit (Aldrete Score ≥ 9 equals the hypothetic discharge time from post anesthetic care unit)
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
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.
Minimum age: 18 Years.
Maximum age: 75 Years.
- 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)
- 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
- 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
- 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
Locations and Contacts
RWTH Aachen University; Department of Anesthesiology, Aachen D-52074, Germany
Starting date: November 2008
Last updated: May 16, 2011