Clinical trial NCT03630887: Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection
Official title: Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia; Anesthesia
Perioperative/Postoperative Complications
Complication of Anesthesia
Temperature Change, Body
Anaesthesia Complication
Transurethral Resection Syndrome
Keywords: Prewarming
Tympanic temperature
Transurethral Resection
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
Collaborators: name: University of Las Palmas de Gran Canaria
First posted: 2018-08-15
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes.

Sample size was authorized by IRB to be changed from 144 to 244 (61 patients per group) due to possible missing data.
Primary purpose: PREVENTION

Brief summary: Hypothermia is a frequent perioperative complication. When the negative effects of anesthesia on temperature are aggravated by other factors, such as glycine infusion in transurethral resection, temperature can decrease even more. Preoperative warming prevents hypothermia, lowering the temperature gradient between core and peripheral compartments and reducing thermal redistribution. The most recent clinical practice guidelines advocate for active prewarming before induction of general anaesthesia since it is very effective in preventing perioperative hypothermia. However, the ideal warming time prior to the induction of anesthesia has long been investigated. This study aims to evaluate the optimal time period of preoperative forced-air warming to reduce the incidence of hypothermia at the end of surgery in patients submitted to transurethral resection. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. We will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 144 patients are going to be included in this study (36 patients in each group). Measurement of temperature will be performed using a tympanic thermometer. 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: Maintaining patient's temperature above 36 grades Celsius throughout the perioperative period is challenging. Thus, it is essential to monitor temperature in order to be able to take measures to avoid the appearance of hypothermia. Once the temperature has decreased, its treatment is difficult since the application of heat to the body surface takes a long time to reach the core thermal compartment. Intraoperative warming alone cannot avoid postoperative hypothermia. The application of forced-air warming system during the preoperative period has been shown to be the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, it would not be efficient to provide a long-time prewarming in short-term surgical procedures. Thus, the ideal warming time prior to the induction of anesthesia has long been investigated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection, the conductance of this clinical trial is justified.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective Transurethral resection under general or 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:

* American Society of Anesthesiologists physical status classification I - III.
* Pregnancy.
* Active infection.
* Intake of antipyretics within 24 hours before surgery.
* Neuropathy.
* Thyroid disorders.
* Peripheral vascular disease.
* Skin lesions.
* History of hypersensitivity to skin contact devices.

Primary outcomes:
measure: Differences in Body Temperature among different treatment groups (using tympanic and esophageal thermometers)
timeFrame: Throughout surgery, an average of 60 minutes.
Secondary outcomes:
measure: Length of stay in Post-Anesthetic Care Unit (in minutes)
timeFrame: Stay in Post-Anesthetic Care Unit, an average of 6 hours.
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 University Hospital
name: Ángel Becerra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Becerra A, Valencia L, Saavedra P, Rodriguez-Perez A, Villar J. Effect of prewarming on body temperature in short-term bladder or prostatic transurethral resection under general anesthesia: A randomized, double-blind, controlled trial. Sci Rep. 2021 Oct 21;11(1):20762. doi: 10.1038/s41598-021-00350-2.