Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia

Previous research has shown beneficial effects of prewarming on preventing inadvertent perioperative hypothermia (IPH). Warming the surface of the body before the induction of anesthesia can reduce the temperature difference between the core and periphery, thereby reducing the degree of core-to-peripheral thermal redistribution. It has been proved that initiation of warming before surgery can be more useful for preventing IPH than warming only during surgery. Nevertheless, there are not many researches on effects of short period (<30 min) prewarming, especially in gynecologic laparoscopic surgery. Accordingly, the investigators designed this study to test if IPH can be effectively prevented when 10 minutes of prewarming is added to intraoperative active warming in patients undergoing gynecologic laparoscopic surgery.

Study Overview

• Status: Completed
• Conditions: Hypothermia; Anesthesia
• Intervention / Treatment: Device: Prewarming

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42472
    • DaeguCUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA physical status 1 or 2 patients
• patients who underwent gynecologic laparoscopic surgery under general anesthesia

Exclusion Criteria:

• preexisting hypothermia (<36℃) or hyperthermia (>37.5℃)
• anesthesia last for <1 hour or >2 hours
• conversion from laparoscopic surgery to laparotomy
• patients with a body mass index (BMI) ≥ 31kg/m2
• patients with known thyroid disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prewarming group; Participants in Prewarming group was warmed with forced air warming device (WarmTouch WT 6000 Warming Unit, Medtronic, Minneapolis, MN, USA) over the entire body for 10 minutes before anesthesia was induced in the operating theater. All participants received active warming with forced air warming system from the initiation of anesthetic induction until end of surgery.	Device: Prewarming; In the operating theater, participants allocated in Prewarming group received 10 min-prewarming, which is cutaneous warming before induction of anesthesia. For prewarming, forced air warming system (WarmTouch WT 6000 Warming Unit, Medtronic, Minneapolis, MN, USA) was used and the warming temperature of the device was set to 45°C.
NO_INTERVENTION: Non-prewarming group; In Non-prewarming group, no active warming was conducted before induction of anesthesia. Only standard care was provided with introperative active warming with forced air warming system from the initiation of anesthetic induction until end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of intraoperative hypothermia	Number of Participants whose core temperature was than 36℃ was recorded at each time point.	on arrival at operating theater, before anesthesia induced, every 15 minutes after anesthetic induction until admission to the post anesthetic care unit (PACU)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of postoperative shivering	Number of Participants who suffer shivering at the post anesthetic care unit was recorded. Postoperative shivering was graded by an investigator who did not know the procedure in the operating room; shivering grade was divided into four grades (0 = none, 1 = mild, 2 = moderate, 3 = severe, The Bedside Shivering Assessment Scale)	on the admission to PACU, 30 minutes after the admission to PACU
Time-temperature interaction during the first 1 hour of anesthesia	Core body temperature was recorded at each time point. Time-temperature interaction of 2 groups during the first 1 hour of anesthesia was analyzed by RMANOVA	Core body temperature was recorded at 15-min intervals from initiation of anesthesia for 1 hour.

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center
• Investigators: Principal Investigator: Jin Yong Jung, MD, Daegu Catholic University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2019
• Primary Completion (ACTUAL): March 19, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (ACTUAL): July 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Prewarming; Perioperative hypothermia; Core body temperature; Gynecologic laparoscopic surgery
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: CR-18-174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No