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

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Other: no warming; Other: pre-warming

• Registration Number: NCT03184506
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-08
• Study Start: 2017-06-12
• Study First Posted: 2017-06-12
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Last Update Submitted: 2019-02-28
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Adult patients with ASA physical status I-III, aged 50 - 80 years, undergoing HoLEP under spinal anesthesia

Exclusion Criteria

• preoperative body temperature of more than 37.2°C preexisting severe cardiovascular, respiratory and endocrinal disease on anticoagulant therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	no warming	-
pre-warming group	pre-warming	-

Primary Outcome Measures

Name	Time	Method
core temperature	on admission to PACU	taken in the same ear using an infrared tympanic thermometer (ThermoScan IRT 1020; Braun, Germany), and the highest reading from three consecutive measurements was recorded.

Secondary Outcome Measures

Name	Time	Method
Thermal comfort	on arrival at the OR, at every 30 minutes after spinal anesthesia, on admission to PACU, and then every 30 minutes for 1 hour.	evaluated using a numeric rating scale: 0 was defined as 'extremely cold', 5 as 'thermally neutral', and 10 as 'extremely hot'
the incidence of perioperative hypothermia	at baseline (preoperative care unit), on arrival at the OR, every 10 minutes after spinal anesthesia, and on admission to PACU 1 hour	Hypothermia defined as a core temperature less than 36.0°C in according to the current guideline. The number of patients who became hypothermic at each time was recorded.
core temperature	at baseline (preoperative care unit), on arrival at the operation room, every 30 minutes after spinal anesthesia	taken in the same ear using an infrared tympanic thermometer (ThermoScan IRT 1020; Braun, Germany), and the highest reading from three consecutive measurements was recorded.
the incidence of shivering	on arrival at the OR, at every 30 minutes after spinal anesthesia, on admission to PACU, and then every 30 minutes for 1 hour.	graded using 4 point scale (0 = no shivering; 1 = shivering localized to the core and neck; 2 = shivering including the upper extremities; and 3 = total body shivering)

Trial Locations

Locations (1)

Kangnam Sared heart Hospital; 🇰🇷 Seoul, Yeongdeungpo-gu, Korea, Republic of