Postoperative Nausea Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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