Hypothermia
Conditions
Keywords
prewarming, perioperative hypothermia, microdialysis, tissue oxygen saturation, cytoreductive surgery
Brief summary
The primary purpose of this study is to determine whether a prewarming period of at least 30 minutes during induction of general and combined epidural anesthesia reduces the core temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal surgery. In addition the effect of prewarming on intra and postoperative body core temperature will be evaluated.
Interventions
OTHERPrewarming
Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.
DEVICEMicrodialysis
71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden
Sponsors
Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 * elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary
Exclusion criteria
* age \< 18 * refusal participate in study * pregnant or breast-feeding women * cardiac ejection fraction \< 30% * terminal renal insufficiency requiring dialysis * severe pulmonary disease (Gina-Classification\< 3) * neurological and/or psychiatric disease * patient is placed in an institution due to court order * lack of language skills/understanding * employee of Charité Berlin * alcohol addiction * refusal of epidural anesthesia or failure to insert epidural catheter * participation in other perioperative, invasive studies which prohibit further study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body core temperature drop from induction of anesthesia to start of surgery | approximately 30-40 minutes |
Secondary
| Measure | Time frame |
|---|---|
| body core temperature at the end of surgery | duration of surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| prolonged need for ventilatory support | 10 days postoperative | Goal is to determine whether discrepancies between the different groups regarding prolonged postoperative need for ventilatory support.Defined through length of ventilation after surgery (hours) |
| Changes in Microcirculation | duration of surgery | Goal is to determine whether the prewarming and hypothetically improved perioperative warming results in increased microcirculation determined through microdialysis.Measured in lactate/pyruvate (µmol/L) ratio |
Countries
Germany
Contacts
Primary ContactMichael Sander
Outcome results
None listed