Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery (THER-6)

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Prewarming; General Anaesthesia; Preoperative Warming; Epidural Anaesthesia; Perioperative Hypothermia; Temperature Monitoring

Treatments: Device: Forced-air warming

Study type: Interventional

Funder types: Other

Identifiers

NCT01795482

THER-6

Details and patient eligibility

About

The study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.

Full description

The aim of our study is to evaluate the performance of different durations of active preoperative skin-surface warming (prewarming) to prevent perioperative hypothermia in patients undergoing major abdominal surgery under combined general/epidural anaesthesia. The investigators plan to enroll 99 patients in 3 groups. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 years
• planned duration of surgery > 2 hours
• planned for elective major abdominal surgery under combined epidural/general anaesthesia
• written informed consent
• American society of anesthesiologists status 1-3

Exclusion criteria

• duration of surgery < 90 min
• withdrawal of consent
• emergency surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups

Group 2, Prewarming only before general anaesthesia

Experimental group

Description:

Active forced-air warming for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C).

Treatment:

Device: Forced-air warming

Group 3, Prewarming before epidural and general anaesthesia

Experimental group

Description:

Active forced-air warming for 15 min before start of epidural anaesthesia and for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C).

Treatment:

Device: Forced-air warming

Group 1, control group

No Intervention group

Description:

No active warming before start of epidural or general anaesthesia, active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C).