This protocol describes a total of three studies that are intrinsically linked. It does therefore have three titels. 1. The effect of xenon and sevoflurane on depth of hypnosis monitors when titrated to standard anaesthesia 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.

• Register: EUCTR
• Last refreshed on: 3 July 2012
• Main ID: EUCTR2008-004132-20-DE
• Date of registration: 10/09/2008
• Prospective Registration: Yes
• Primary sponsor: Air Liquide Santé International
• Public title: This protocol describes a total of three studies that are intrinsically linked. It does therefore have three titels. 1. The effect of xenon and sevoflurane on depth of hypnosis monitors when titrated to standard anaesthesia 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.
• Scientific title: This protocol describes a total of three studies that are intrinsically linked. It does therefore have three titels. 1. The effect of xenon and sevoflurane on depth of hypnosis monitors when titrated to standard anaesthesia 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.
• Date of first enrolment: 07/11/2008
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004132-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: Parallel group: yes Cross over: Other: yes Other trial design description: Multi-factorial If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
Patients = 18 < 75 years; ASA physical status I-II; Planned duration of anaesthesia > 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

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
Concentration number: 100-

Product Name: Sevoflurane
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: SEVOFLURANE
CAS Number: 28523866
Concentration unit: % (V/V) percent volume/volume
Concentration type: range
Concentration number: 0.8-1.1

Product Name: Dexamethason
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50022
Concentration unit: mg milligram(s)
Concentration number: 4-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use

Product Name: Ondansetron
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: ONDANSETRON
CAS Number: 116002701
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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

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.

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

Secondary ID(s)

ALS-8-08-A-401