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ISRCTN
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ISRCTN01110844
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ClinicalTrials.gov identifier
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Public title
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An investigative study into the recovery index, attentiveness and state of memory after xenon or isoflurane anaesthesia
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Scientific title
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A single centre randomised controlled investigative study into the recovery index, attentiveness and state of memory after xenon or isoflurane anaesthesia
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Acronym
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N/A
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Serial number at source
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23/2002
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Study hypothesis
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The aim of the study was to evaluate the efficacy of two balanced anaesthetic regimens with respect to recovery of early post-operative cognitive function at the day of operation (assessed as attentiveness and memory; this was the primary criterion) and emergence profile (assessed as the recovery index; this was the secondary criterion). The hypothesis was primarily that patients have a significantly higher status of attentiveness and memory 1 and 3 hours after inhalation anaesthesia with xenon compared to isoflurane anaesthesia, and that patients reach their pre-operative level of cognitive function within 3 hours after extubation. The second hypotheses was that the time to wake up from the anaesthetic was predicted to be shorter following xenon than following isoflurane.
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Lay summary
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Ethics approval
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Ethics Committee of the University Witten/Herdecke approved on the 11th September 2002 (ref: 23/2002). Patient insurance by Winterthur International (ref: DE 00020283-LI-02A-715).
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Study design
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Single centre single blind randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Post-operative cognitive function
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Participants - inclusion criteria
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1. Healthy American Society of Anaesthesiologists (ASA) grade I and II patients
2. Aged over 18 years of age, either sex
3. Scheduled for four different types of elective surgery. The types of surgery were:
3.1. Visceral surgical strumectomy
3.2. Augmentation or reduction mammaplasty
3.3. Liposuction in obese patients
3.4. Knee arthroscopy
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Participants - exclusion criteria
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1. Patients with ASA classification grade greater than 2
2. Aged less than 18 years
3. Emergency surgery
4. Alcohol or drug abuse
5. Organ dysfunction of liver, kidney or pulmonary system
6. Diabetes
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Anticipated start date
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01/06/2003
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Anticipated end date
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31/05/2005
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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61
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Interventions
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ASA I and II patients undergoing both long and short surgical interventions were randomised to receive either general anaesthesia with xenon or general anaesthesia with isoflurane. The inhalational anaesthesia was carried out following standard procedures using appropriate equipment.
Patients were randomised in blocks of 4 - 8 patients in order to balance the groups. The varying size of blocks was to counteract the differing frequencies of the operations and also any influence of duration and invasiveness of the operations. A total of 61 patients who met the pre-defined inclusion and exclusion criteria were randomised either to receive xenon in oxygen (Xenon group, n = 31) or isoflurane in stickoxydal (Isoflurane group, n = 30).
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Primary outcome measure(s)
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Syndrome Short Test
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Secondary outcome measure(s)
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1. Recovery Index
2. Aldrete Score
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Sources of funding
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Messer Griesheim/AIR LIQUIDE Medical GmbH (Germany)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20459661
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Contact name
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Dr
Ralph
Stuttmann
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Address
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Mersburgerstraße 165
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City/town
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Halle ( Saale)
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Zip/Postcode
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06112
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Country
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Germany
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Email
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ralph.stuttmann@bergmannstrost.com
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Sponsor
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BG-Kliniken Bergmannstrost (Germany)
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Address
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c/o PD Dr. med. Ralph Stuttmann
Merseburgerstraße 165
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City/town
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Halle
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Zip/Postcode
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06112
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Country
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Germany
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Email
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ralph.stuttmann@bergmannstrost.com
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Sponsor website:
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http://www.bergmannstrost.com
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Date applied
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30/12/2009
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Last edited
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25/05/2010
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Date ISRCTN assigned
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16/03/2010
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