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
|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|
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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
The effect of xenon as an anaesthetic on the depth of hypnosis.
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
Inhalation gas; age adapted MAC-values; the duration of the treatment will be defined through anesthesia-time
Other Name: Sevorane
Dexamethasone as prevention of postoperative nausea and vomiting after xenon or sevoflurane anesthesia
Intravenous use, 4 mg, single shot
Other Name: Fortecortin Inject
|Placebo Comparator: 4||
Intravenous use; single shot
Ondansetron, to determine the onset-time of ondansetron when used as rescue medication for postoperative nausea and vomiting
Intravenous use; 4 mg; single shot
Other Name: Zofran
|Placebo Comparator: 6||
Intravenous use; single shot
- The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure. [ Time Frame: During anaesthesia ]
- 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. ]
- 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. ]
- Heart rate and blood pressure [ Time Frame: During anesthesia ]
- Observer´s assessment of alertness and sedation scales [ Time Frame: Recovery from anesthesia ]
- Sensitivity and specificity characteristics for both the BIS and the cAAI. [ Time Frame: During anesthesia ]
- Awareness after anesthesia assessed by the Brice questionnaire at 2 and 24 hours after anesthesia. [ Time Frame: 24 hours after anaesthesia ]
- 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 ]
- Usage of rescue medication, time and dosage [ Time Frame: 24 hours postoperative ]
- 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 ]
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
|RWTH Aachen University; Department of Anesthesiology|
|Aachen, Germany, D-52074|
|Study Chair:||Rolf Rossaint, MD||RWTH University Aachen; Department of Anesthesiology|