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

NCT ID: NCT04027842

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2019-06-30

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.

Conditions

Hypothermia; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Prewarming group

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.

Group Type: EXPERIMENTAL

Prewarming

Intervention Type: 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.

Non-prewarming group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Daegu Catholic University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jin Yong Jung

Professor of anesthesiology and pain medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Yong Jung, MD

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Locations

DaeguCUMC

Daegu, , South Korea

Countries

South Korea

Other Identifiers

CR-18-174

Identifier Type: -

Identifier Source: org_study_id