Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

Postoperative Complications Clinical Trial

Official title:

Prevention of Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617809
• Other study ID #: 2018-089-1
• Status: Completed
• Start date: August 6, 2018
• Est. completion date: October 24, 2019

Study information

• Verified date: July 2020
• Source: Dr. Negrin University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 24, 2019
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Body Temperature Changes
• Hypothermia
• Hypothermia; Anesthesia
• Intraoperative Complications
• Peroperative Complication
• Postoperative Complications
• Surgical Site Infection
• Surgical Wound Infection
• Temperature Change, Body

Intervention

Procedure:
• Preoperative warming
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ángel Becerra	University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature	Asses the effect of prewarming in maintaining body temperature of patients undergoing elective laparoscopic urological surgery.	Through perioperative period, an average of 7 hours
Primary	Temperature	Differences in body core temperature throughout the perioperative period among different groups	From the arrival to the pre-anesthesia room to one hour after the arrival to the postanesthetic care unit an average of 7 hours.
Secondary	Surgical site infection	Asses the effect of prewarming in preventing surgical site infection of patients undergoing elective laparoscopic urological surgery.	Through patient's stay in hospital, an average of 15 days
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 laparoscopic urological surgery.	Immediate postoperative period, an average of 1 hour.
Secondary	Risk factors of perioperative hypothermia	To assess the effect of perioperative factors, related to the characteristics of patients and the surgery on provoking a greater drop of perioperative temperature.	Throughout the perioperative period, an average of 7 hours.
Secondary	Perioperative bleeding	Asses the effect of prewarming on decreasing perioperative bleeding of patients undergoing elective laparoscopic urological surgery.	Throughout the perioperative period, an average of 7 hours.
Secondary	Postoperative pain, using the visual analogue scale, from 0 to 10	Asses the effect of prewarming on decreasing postoperative pain of patients undergoing elective laparoscopic urological surgery.	Immediate postoperative period, an average of 1 hour.