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Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial

Preoperative Active Warming Prevents Postoperative Hypothermia in Patients Undergoing Laparoscopic Gynecologic Surgery. A Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02518815
Enrollment
42
Registered
2015-08-10
Start date
2013-05-31
Completion date
2014-01-31
Last updated
2015-08-10

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

Conditions

Body Temperature Changes, Hypothermia, Hypothermia, Accidental, Hypothermia Due to Anesthetic, Hypothermia Following Anesthesia

Brief summary

This study examined whether 20 minutes of prewarming prior to gynecological laparoscopic surgery prevented inadvertent post-operative hypothermia. Treatment group received prewarming using a forced air body warming, control group received no active warming system. Both groups were then warmed with forced air warmer intraoperatively.

Detailed description

Inadvertent perioperative hypothermia is a well known perioperative complication. The behavioural response to hypothermia is the most powerful protective tool, more effective than any autonomic response, and is obviously removed in the operative setting. Anesthesia alters thermoregulation by profoundly changing the thresholds for vasoconstriction and shivering, making patients vulnerable to the adverse outcomes related to mild hypothermia. Inadvertent postoperative hypothermia can occur in up to 70% of surgical patients. It is defined as a core temperature below 36°C (96.8°F). The aim of this study was to determine if prewarming with an active warming system for 20 minutes preoperatively could prevent postoperative inadvertent hypothermia.

Interventions

DEVICE3M Bair Paws Warming System

20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system

Sponsors

Michael Garron Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ASA I-III * undergoing elective laparoscopic gynecological surgical procedures * expected duration \>60 minutes * BMI 18-45

Exclusion criteria

* Current fever (temperature\>38.1°C) * active endocrine disorders were

Design outcomes

Primary

MeasureTime frameDescription
Oral temperature immediately postoperativelyImmediately post-operativelyImmediate postoperative oral temperature on admission to the post-anesthetic care unit.

Secondary

MeasureTime frameDescription
Oral temperature 30 minutes postoperatively30 min after admission to post-anesthetic care unitOral temperature 30 minutes after admission to the post-anesthetic care unit.
Oral temperature at discharge from post-anesthetic care unitDischarge from post-anesthetic care unit (average 99 minutes)Oral temperature upon discharge from the post-anesthetic care unit.
11-point Pain score30 min after admission to post-anesthetic care unit11-point VAS pain score postoperatively measured 30 minutes after admission to the post-anesthetic care unit

Countries

Canada

Outcome results

None listed

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