Clinical Trials Directory

Trials / Completed

CompletedNCT03184506

Effect of Pre-warming on Perioperative Hypothermia During HoLEPunder Spinal Anesthesia

Effect of Pre-warming on Perioperative Hypothermia and Shivering During Holmium Laser Enucleation of the Prostate (HoLEP) Under Spinal Anesthesia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Hallym University Kangnam Sacred Heart Hospital · Academic / Other
Sex
Male
Age
50 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below 36°C. Intraoperative hypothermia can lead to serious clinical complications such as, myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection. Hypothermia develops easily during surgeries that require irrigation fluid, such as laparoscopic surgery and transurethral resection of the prostate. Although isothermic irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to warm a large volume of irrigation fluid. Re-distribution after induction of anesthesia is the most important cause of perioperative hypothermia. The extent of re-distribution is proportional to the gradient between the core and peripheral compartments. Pre-warming increases the heat content of the peripheral thermal compartment, reducing the gradient for redistribution. Recently, A recent-meta analysis suggested that as a single strategy, preoperative forced air warming had significant benefits than other warming methods. Also, it was reported that only 20 (or even 10) min of pre-warming mostly prevented patients from perioperative hypothermia under general anesthesia. However, few studies have examined whether short time pre-warming can reduce hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia. The purpose of this study is to assess whether the application of preoperative forced air warming set to high temperature (\> 43°C) for brief period can prevent hypothermia or shivering during procedures requiring large volumes of cold irrigation.

Conditions

Interventions

TypeNameDescription
OTHERpre-warmingOn arrival at the preoperative care unit, assignments were determined using an opaque sealed envelope opened by investigator with no clinical involvement in the study. In the pre-warming group, the forced-air blanket (COVIDIEN™ WarmTouch™ Full Body/Multi Access Blanket, Covidien Ilc, Mansfield, MA, USA) was positioned over the whole body except head and neck, covered by cotton blanket. Forced air warmer (COVIDIEN™ WarmTouch™ WT6000 Warming Unit, Covidien Ilc, Mansfield, MA, USA) was set to 'high level' (45℃) during 20 min. During the warming procedure, patients were asked every 5 min about their thermal comfort; if they felt overheated, the warmer was lowered to 41℃
OTHERno warmingpatients were covered only with two layers of cotton blanket

Timeline

Start date
2017-06-12
Primary completion
2017-12-31
Completion
2017-12-31
First posted
2017-06-12
Last updated
2019-03-04

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03184506. Inclusion in this directory is not an endorsement.