Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia

Not Applicable

Completed

• Conditions: Hypothermia; Anesthesia; Perioperative Complication; Regional Anesthesia Morbidity; Transurethral Resection Syndrome; Temperature Change, Body
• Interventions: Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

• Registration Number: NCT04252820
• Lead Sponsor: Dr. Negrin University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-03-01
• Status Verified: 2020-08
• Primary Completion: 2020-08-04
• Study Completion: 2020-08-04
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prewarming during 30 minutes	WarmTouch total body blanket, Covidien Ltd, Mansfield, USA	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.
Prewarming during 45 minutes	WarmTouch total body blanket, Covidien Ltd, Mansfield, USA	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.
Prewarming during 15 minutes	WarmTouch total body blanket, Covidien Ltd, Mansfield, USA	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.

Primary Outcome Measures

Name	Time	Method
Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor	Throughout surgery, an average of 60 minutes.	To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection under spinal anesthesia

Secondary Outcome Measures

Name	Time	Method
Length of stay in postanesthetic care unit (in minutes)	Stay in Post-Anesthetic Care Unit, an average of 6 hours.	To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection under spinal anesthesia.
Postoperative pain, using visual analogue scale (from 0 to 10)	Immediate postoperative period, an average of 1 hour.	To assess the effect of prewarming in reducing the postoperative pain at the arrival to the postanesthetic care unit of patients undergoing elective transurethral resection under spinal anesthesia
Postoperative shivering (using a dichotomous scale: yes or no)	Immediate postoperative period, an average of 1 hour	To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection under spinal anesthesia

Trial Locations

Locations (1)

Ángel Becerra; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain