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

NCT04027842 | Completed

• 1 other identifier: CR-18-174
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the incidence of postoperative shivering

  on the admission to PACU, 30 minutes after the admission to PACU

• 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.

Study Arms (2)

Prewarming group

EXPERIMENTAL

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.

Device: Prewarming

Non-prewarming group

NO INTERVENTION

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.

Interventions

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.

Prewarming group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status 1 or 2 patients
• patients who underwent gynecologic laparoscopic surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

DaeguCUMC

Daegu, 42472, South Korea

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

• Jin Yong Jung, MD

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesiology and pain medicine

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 22, 2019
• Study Start: January 9, 2019
• Primary Completion: March 19, 2019
• Study Completion: June 30, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)