Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia

Dr. Negrin University Hospital

Status: Completed

Conditions: Perioperative Complication; Hypothermia; Anesthesia; Temperature Change, Body; Regional Anesthesia Morbidity; Transurethral Resection Syndrome

Treatments: Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Study type: Interventional

Funder types: Other

Identifiers

NCT04252820

RTU-Spinal

Details and patient eligibility

About

Perioperative hypothermia is one of the most common anaesthetic complications, increasing the morbidity/mortality of our patients. Active prewarming with hot forced-air devices has demonstrated to be the most effective tool to prevent hypothermia, but its use is only recommended in long-term surgeries and the optimal prewarming duration has not been elucidated. Both spinal anaesthesia associated to the irrigation with liquids at low temperature instilled during transurethral resection (TUR) cause a decrease in the core temperature of the patient. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. Our aim is to assess the effect of different time-periods of prewarming on preventing perioperative hypothermia during TUR with spinal anaesthesia. Investigators will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 200 patients are going to be included in this study (50 patients in each group). Measurement of temperature will be performed using a tympanic thermometer and zero-heat-flux temperature sensor. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.

Full description

Inadvertent perioperative hypothermia is probably the most common anaesthetic complication. Its appearance increases the morbidity of the surgical patient, increasing the incidence of cardiac events or perioperative blood loss and causes a greater time of recovery from anaesthesia. Prewarming is the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, prewarming in patients submitted to spinal anesthesia is still a weak recommendation and the optimal prewarming time has not been elucidated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection under spinal anaesthesia, the conductance of this clinical trial is justified.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective Transurethral resection under spinal anesthesia.
• Patients older tan 18 years old.
• American Society of Anesthesiologists physical status classification I - III.
• Absence of cognitive impairment.
• Written informed consent before enrollment.

Exclusion criteria

• Pregnancy.
• American Society of Anesthesiologists physical status classification IV.
• Active infection.
• Intake of antipyretics within 24 hours before surgery.
• Thyroid disorders.
• Skin lesions or History of hypersensitivity to skin contact devices.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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215 participants in 4 patient groups

Control

No Intervention group

Description:

No prewarming. Patients will be actively warmed during the intraoperative period. Tympanic thermometer and zero-heat-flux temperature sensor will be used to measure the temperature throughout the perioperative period.

Prewarming during 15 minutes

Experimental group

Description:

Active Prewarming will be performed during 15 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.

Treatment:

Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Prewarming during 30 minutes

Experimental group

Description:

Active Prewarming will be performed during 30 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.

Treatment:

Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Prewarming during 45 minutes

Experimental group

Description:

Active Prewarming will be performed during 45 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.

Treatment:

Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA