1. The effect of xenon and sevoflurane on depth of hypnosis monitors when titrated to standard anesthesia parameter. 2. The efficacy of dexamethasone for prevention of PONV after xenon or sevoflurane. 3. Ondansetron as rescue for the treatment of established PONV after xenon or sevoflurane.
Conditions
Interventions
Trade Name: LENOXe 100% (V/V)
Product Name: Xenon
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Xenon
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentrati
Sponsors
Air Liquide Santé International
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients = 18 60 min; Apfel score = 2-3; elective (laparoscopic) surgery (abdominal, gynaecological) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hystory of hypersensitivity to any used drugs in this trial; malignant hyperthermia; elevated intracranial pressure; preeclampsia or eclampsia, lung and/or airway disease; risk of high oxygen consumption; coronary heart disease and/or seriously impaired cardiac function; liver and/or kidney function disorders; pregnancy and lactation; hearing disorders; history of liver function disorders, leucocytosis and unclear fever after usage of halogenated anaesthetics; porphyria; acute infection; presumed uncooperativeness or legal incapacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the effect of xenon or sevoflurane on the depth of hypnosis as assessed by the Bispectral Index (BIS) and the Composite Auditory Evoked Potential Index (cAAI) when titrated according to standard clinical parameter. 2. To demonstrate that dexamethasone prevents PONV equally well after xenon or sevoflurane. 3. To determine the onset-time of ondansetron when used as rescue medication for postoperative nausea and vomiting. ;Secondary Objective: Heart rate and blood pressure; Observer´s assessment of alertness and sedation scales; sensitifity and specificity characteristics for both the BIS and the cAAI; awareness after anaesthesia assessed by the Brice questionnaire at 2 and 24 hours after anaesthesia; occurrence of postoperative vomiting and the respective time-points; usage of rescue medication, time and dosage; time to discharge from post anaesthetic care unit;Primary end point(s): 1. The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure. 2. Postoperative nausea as assessed by a verbal rating scale (VRS) ranging between 0 and 10 after anaesthesia at 5, 10, 15, 30, 45, 60, and 90 min. At 2, 6 and 24 h after anaesthesia 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. Thereafter 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 | — |
Countries
Germany
Outcome results
None listed