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Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

Prevention of Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03617809
Enrollment
99
Registered
2018-08-06
Start date
2018-08-06
Completion date
2019-10-24
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Prewarming, Perioperative hypothermia, Esophageal thermometer

Brief 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.

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, 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.

Interventions

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.

Sponsors

University of Las Palmas de Gran Canaria
CollaboratorOTHER
Ángel Becerra
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
TemperatureThrough perioperative period, an average of 7 hoursAsses the effect of prewarming in maintaining body temperature of patients undergoing elective laparoscopic urological surgery.

Secondary

MeasureTime frameDescription
Surgical site infectionThrough patient's stay in hospital, an average of 15 daysAsses the effect of prewarming in preventing surgical site infection of patients undergoing elective laparoscopic urological surgery.
Postoperative shivering (using a dichotomous scale: yes or no)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.
Risk factors of perioperative hypothermiaThroughout 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.
Perioperative bleedingThroughout the perioperative period, an average of 7 hours.Asses the effect of prewarming on decreasing perioperative bleeding of patients undergoing elective laparoscopic urological surgery.
Postoperative pain, using the visual analogue scale, from 0 to 10Immediate postoperative period, an average of 1 hour.Asses the effect of prewarming on decreasing postoperative pain of patients undergoing elective laparoscopic urological surgery.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026