Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

Perioperative/Postoperative Complications Clinical Trial

Official title:

Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630887
• Other study ID #: RTU-2018-153-1
• Status: Completed
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: June 2020
• Source: Dr. Negrin University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaesthesia Complication
• Body Temperature Changes
• Complication of Anesthesia
• Hypothermia
• Hypothermia; Anesthesia
• Perioperative/Postoperative Complications
• Postoperative Complications
• Temperature Change, Body
• Transurethral Resection Syndrome

Intervention

Device:
• WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Forced-air warming will be applied in the preanesthetic room during different time periods.

Locations

Country	Name	City	State
Spain	Ángel Becerra	Las Palmas De Gran Canaria	Las Palmas

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital	University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Body Temperature among different treatment groups (using tympanic and esophageal thermometers)	To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection.	Throughout surgery, an average of 60 minutes.
Secondary	Length of stay in Post-Anesthetic Care Unit (in minutes)	To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection.	Stay in Post-Anesthetic Care Unit, an average of 6 hours.
Secondary	Postoperative shivering (using a dichotomous scale: yes or no)	To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection.	Immediate postoperative period, an average of 1 hour.