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

Primary Purpose

Hypothermia; Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prewarming
Sponsored by
Daegu Catholic University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia; Anesthesia focused on measuring Perioperative hypothermia, Core body temperature, Prewarming, Gynecologic laparoscopic surgery

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • DaeguCUMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prewarming group

Non-prewarming group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the incidence of intraoperative hypothermia
Number of Participants whose core temperature was than 36℃ was recorded at each time point.

Secondary Outcome Measures

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)
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

Full Information

First Posted
July 12, 2019
Last Updated
July 19, 2019
Sponsor
Daegu Catholic University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04027842
Brief Title
Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia
Official Title
Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daegu Catholic University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia
Keywords
Perioperative hypothermia, Core body temperature, Prewarming, Gynecologic laparoscopic surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prewarming group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-prewarming group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prewarming
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of intraoperative hypothermia
Description
Number of Participants whose core temperature was than 36℃ was recorded at each time point.
Time Frame
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 Measure Information:
Title
the incidence of postoperative shivering
Description
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)
Time Frame
on the admission to PACU, 30 minutes after the admission to PACU
Title
Time-temperature interaction during the first 1 hour of anesthesia
Description
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
Time Frame
Core body temperature was recorded at 15-min intervals from initiation of anesthesia for 1 hour.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Yong Jung, MD
Organizational Affiliation
Daegu Catholic University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaeguCUMC
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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