Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial

Not Applicable

• Conditions: Hypothermia
• Interventions: Other: Prewarming; Device: Microdialysis

• Registration Number: NCT02364219
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-20
• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-16
• Study First Posted: 2015-02-18
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20
• Primary Completion: 2016-02
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prewarm + Microdialysis	Prewarming	Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia and Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue
Prewarm + Microdialysis	Microdialysis	Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia and Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue
Prewarm	Prewarming	Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.
Standard + Microdialysis	Microdialysis	Study arm in which patients are treated according to standard operating procedures but also receive Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue.

Primary Outcome Measures

Name	Time	Method
body core temperature drop from induction of anesthesia to start of surgery	approximately 30-40 minutes

Secondary Outcome Measures

Name	Time	Method
body core temperature at the end of surgery	duration of surgery

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany