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

Hypothermia; Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027842
• Other study ID #: CR-18-174
• Status: Completed
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 30, 2019
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	DaeguCUMC	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.