Skip to main content
OpenTrials
Completed

NCT Number: NCT03617809

Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as perioperative bleeding or surgical site infection. Once the temperature has decreased, its treatment is difficult.

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 if different time periods of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery in patients submitted to laparoscopic urological surgery under general anesthesia. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to laparoscopic prostatectomy or nephrectomy between August and December 2018. In this study 64 - 96 patients will be included and prewarming will be applied following routine clinical practice. The prewarming time will depend on the time the patient has to wait before entering in the operating theatre. Measurement of temperature will be performed using an esophagic 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.

Completed

Looking for future studies?

Notify Me

Key information

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, long time periods of prewarming would not be efficient. Thus, the ideal warming time prior to the induction of anesthesia has long been investigated.

Due to the searching of optimal prewarming time, the conductance of this study 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 laparoscopic urological surgery under general anesthesia.

Exclusion criteria

  • 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

Preoperative warming

Procedure

The prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room.

Primary outcomes

  1. Temperature

    Time frame: Through perioperative period, an average of 7 hours

    Asses the effect of prewarming in maintaining body temperature of patients undergoing elective laparoscopic urological surgery.

  2. Temperature

    Time frame: From the arrival to the pre-anesthesia room to one hour after the arrival to the postanesthetic care unit an average of 7 hours.

    Differences in body core temperature throughout the perioperative period among different groups

Secondary outcomes

  1. Surgical site infection

    Time frame: Through patient's stay in hospital, an average of 15 days

    Asses the effect of prewarming in preventing surgical site infection of patients undergoing elective laparoscopic urological surgery.

  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 laparoscopic urological surgery.

  3. Risk factors of perioperative hypothermia

    Time frame: Throughout the perioperative period, an average of 7 hours.

    To assess the effect of perioperative factors, related to the characteristics of patients and the surgery on provoking a greater drop of perioperative temperature.

  4. Perioperative bleeding

    Time frame: Throughout the perioperative period, an average of 7 hours.

    Asses the effect of prewarming on decreasing perioperative bleeding of patients undergoing elective laparoscopic urological surgery.

  5. Postoperative pain, using the visual analogue scale, from 0 to 10

    Time frame: Immediate postoperative period, an average of 1 hour.

    Asses the effect of prewarming on decreasing postoperative pain of patients undergoing elective laparoscopic urological surgery.

Sponsors and collaborators

Lead sponsor

Ángel Becerra

Other

Collaborators

  • University of Las Palmas de Gran Canaria

Registry information

Official study title

Prevention of Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2018
Registry last updated
Jul 9, 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.

Published trials that share one or more normalized conditions with this study.