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

Not Applicable

Completed

• Conditions: Hypothermia; Anesthesia
• Interventions: Device: Prewarming

• Registration Number: NCT04027842
• Lead Sponsor: Daegu Catholic University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-09
• Primary Completion: 2019-03-19
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-19
• Last Update Submitted: 2019-07-19
• Study First Posted: 2019-07-22
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prewarming group	Prewarming	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the incidence of postoperative shivering	on the admission to PACU, 30 minutes after the admission to PACU	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 15-min intervals from initiation of anesthesia for 1 hour.	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

Trial Locations

Locations (1)

DaeguCUMC; 🇰🇷 Daegu, Korea, Republic of