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NCT Number: NCT04027842

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.

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Key information

Conditions

Hypothermia; Anesthesia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DaeguCUMC

Daegu, 42472, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prewarming

Device

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 outcomes

  1. the incidence of intraoperative hypothermia

    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)

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

Secondary outcomes

  1. the incidence of postoperative shivering

    Time frame: 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)

  2. Time-temperature interaction during the first 1 hour of anesthesia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2019
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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