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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04027842
Enrollment
54
Registered
2019-07-22
Start date
2019-01-09
Completion date
2019-06-30
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia; Anesthesia

Keywords

Perioperative hypothermia, Core body temperature, Prewarming, Gynecologic laparoscopic surgery

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.

Interventions

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.

Sponsors

Daegu Catholic University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of intraoperative hypothermiaon 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

MeasureTime frameDescription
the incidence of postoperative shiveringon the admission to PACU, 30 minutes after the admission to PACUNumber 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 anesthesiaCore 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026