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

Charité University Medicine Berlin

Status: Unknown

Conditions: Hypothermia

Treatments: Device: Microdialysis; Other: Prewarming

Study type: Interventional

Funder types: Other

Identifiers

NCT02364219

EA1/348/14

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Standard

No Intervention group

Description:

Study arm in which patients are treated according to standard operating procedures. Acting as "control arm".

Standard + Microdialysis

Experimental group

Description:

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.

Treatment:

Device: Microdialysis

Prewarm

Experimental group

Description:

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.

Treatment:

Other: Prewarming

Prewarm + Microdialysis

Experimental group

Description:

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

Treatment:

Other: Prewarming

Device: Microdialysis