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Clinical Trials/NCT04252820
NCT04252820
Completed
Not Applicable

Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia

Dr. Negrin University Hospital1 site in 1 country215 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypothermia; Anesthesia
Sponsor
Dr. Negrin University Hospital
Enrollment
215
Locations
1
Primary Endpoint
Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
August 4, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Negrin University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ángel Becerra

Principal Investigator, Anesthesiologist

Dr. Negrin University Hospital

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.

Outcomes

Primary Outcomes

Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor

Time Frame: 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 Outcomes

  • Length of stay in postanesthetic care unit (in minutes)(Stay in Post-Anesthetic Care Unit, an average of 6 hours.)
  • Postoperative pain, using visual analogue scale (from 0 to 10)(Immediate postoperative period, an average of 1 hour.)
  • Postoperative shivering (using a dichotomous scale: yes or no)(Immediate postoperative period, an average of 1 hour)

Study Sites (1)

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