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Completed

NCT Number: NCT02990429

Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery

Perioperative hypothermia is a common problem. It has been defined as a core temperature below 36ºC. The reasons why patient undergoing gynecologic laparoscopic surgery has perioperative hypothermia because the reduced metabolic heat production, redistribution of heat from the core to the periphery and impaired thermoregulation (due to anesthetics), use of cool carbon dioxide gas insufflations and surgical irrigation solution, as well as heat loss due to the cool environment. This perioperative problem has been linked to adverse patient outcomes such as myocardial ischemia as hypothermia increases plasma catecholamine, surgical site infection as hypothermia diminishes wound tissue O2 tension and coagulopathy as hypothermia impairs platelet function.

It claims that perioperative heat loss occurs by radiation (60%), convection (25%) and evaporation (10%). This is caused by the difference between peripheral body and ambient temperature, air circulation around the body and vasodilatation.

In daily practice, most anesthesia personnel warm patient peri-operatively by using force air warmer and intravenous fluid warmer.

This study aimed to compare the difference of core and room temperature in patients undergoing gynecologic laparoscopic surgery by using forced air and intravenous fluid warmer

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Warunee Boayam

Bangkok Noi, Bangkok, 10700, Thailand

About this study

The study was approved from the Siriraj Institutional Review Board (Si-IRB), COA (Certificate of Analysis): Si201/2016 (18/03/2016), and was written informed consent was obtained from all subjects. The study was conducted at the Department of Siriraj Obstetrics and Gynecology.

A total of 90 patients were enrolled in the study between April 2016 and …..2017. All patients underwent general anesthesia for elective gynecologic laparoscopic surgery. Inclusion criteria were patients aged between 18 and 65, elective case, ASA (American Society of Anesthesiologist) physical status class I-III, BMI 25-30 kg/sq.m., surgical time > 90 minutes. Exclusion criteria were the core temperature less than 36ºC or more than 38ºC. Withdrawal or termination criterion was the change of laparoscopic surgery to exploratory laparotomy.

On the day of surgery, participants signed the informed consent and were randomized equally into two groups: A = 45, receiving intraoperative forced air warming and B =45, having intraoperative intravenous fluid via a fluid warmer All patients underwent general anesthesia after application of standard monitors, anesthesia was induced with fentanyl 1-2 mcg/kg or morphine 0.1-0.2 mg/kg., propofol 1.5-2.5 mg/kg, nimbex 1-1.5 mg/kg or atracurium 0.6 mg/kg. Anesthesia was maintained with sevoflurane ,air,O2, supplemented with fentanyl or morphine.

Core temperatures were measured with an electronic thermometer via tympanic membrane. Intraoperatively, core temperatures and room temperatures were measured at 15 minute intervals until the end of surgery .

Postoperative data were measured at 15 minute intervals at the recovery room. Data consisted of vital sign, core temperature, room temperature, shivering, medication requirements and use of heating devices.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA class 1-3, 18-65 years old, BMI 25-30 kg/sq.m., core temperature 36ºC-38ºC, operation more than 90 minutes

Exclusion criteria

  • turn operation to exploratory laparotomy

Treatment and study plan

Forced Air warmer

Procedure
  • record room temperature
  • record core temperature (tympanic membrane)
  • General anesthesia
  • using forced air warmer (bair hugger)
  • Intravenous fluid at room temperature
  • room temperature and core temperature q15 minutes
  • anesthesia finish, stop bair hugger
  • record core temperature before recovery room

Intravenous Fluid Warmer

Procedure
  • record room temperature
  • record core temperature (tympanic membrane)
  • General anesthesia
  • using ranger warmer
  • Intravenous fluid at room temperature
  • room temperature and core temperature q15 minutes
  • anesthesia finish, stop ranger warmer
  • record core temperature before recovery room

Primary outcomes

  1. The difference of core and room temperature in patients undergoing gynecologic laparoscopic surgery (by using forced air and intravenous fluid warmer)

    Time frame: 1 Year

    To study the difference between two groups

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Official study title

Comparison Between Forced Air and Intravenous Fluid Warmers in Gynecologic Laparoscopic Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2016
Registry last updated
Apr 4, 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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