Clinical trial NCT04252820: Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
Official title: Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia; Anesthesia
Perioperative Complication
Regional Anesthesia Morbidity
Temperature Change, Body
Transurethral Resection Syndrome
Keywords: body temperature
hypothermia
prewarming
regional anesthesia
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Different time periods of prewarming will be compared: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor
timeFrame: Throughout surgery, an average of 60 minutes.
Secondary outcomes:
measure: Length of stay in postanesthetic care unit (in minutes)
timeFrame: Stay in Post-Anesthetic Care Unit, an average of 6 hours.
measure: Postoperative pain, using visual analogue scale (from 0 to 10)
timeFrame: Immediate postoperative period, an average of 1 hour.
measure: Postoperative shivering (using a dichotomous scale: yes or no)
timeFrame: Immediate postoperative period, an average of 1 hour
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Ángel Becerra
state: Las Palmas
Study officials:
affiliation: Dr Negrin UH
name: Aurelio Rodríguez-Pérez, PhD
role: STUDY_DIRECTOR
References: