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NCT Number: NCT03630887

Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

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.

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Key information

Conditions

Hypothermia; Anesthesia Anaesthesia Complication Body Temperature Changes Complication of Anesthesia Hypothermia Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Signs and Symptoms Temperature Change, Body Transurethral Resection Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WarmTouch Model 5900, Covidien Ltd, Mansfield, USA

Device

Forced-air warming will be applied in the preanesthetic room during different time periods.

Primary outcomes

  1. Differences in Body Temperature among different treatment groups (using tympanic and esophageal thermometers)

    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.

Secondary outcomes

  1. Length of stay in Post-Anesthetic Care Unit (in minutes)

    Time frame: 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.

  2. Postoperative shivering (using a dichotomous scale: yes or no)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Collaborators

  • University of Las Palmas de Gran Canaria

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2018
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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