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NCT Number: NCT04991272

10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.

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Key information

Conditions

Urologic Diseases Body Temperature Changes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypothermia Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanggye Paik Hospital

Seoul, South Korea

About this study

During general anesthesia, vasodilation distributes body heat and leads to hypothermia. Especially during urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core temperature during operation.

Previous studies have demonstrated that prewarming of the patient is effective in maintaining core temperature perioperatively. However, more than 50% of patients who have applied prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia. Hence, developing simple and effective method to prevent hypothermia is expected.

Hence, the investigators planned to examine the effect of active warming (10 minutes of prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients undergoing urologic surgery(transurethral resection of bladder, prostate)

Exclusion criteria

  • moderate to severe cardiopulmonary, renal impairment
  • thyroid disease
  • any infection sign
  • abnormal temperature prior to induction of general anesthesia (<36'C or >37.5'C)
  • refusal to participate in the study
  • unable to understand the study

Treatment and study plan

prewarming and warmed fluid infusion

Other

prewarming with forced air warming system and warmed fluid infusion.

Primary outcomes

  1. incidence of hypothermia at the end of the operation

    Time frame: approximately 1-2hours after induction (at the end of operation)

    after completion of the operation, number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded.

Secondary outcomes

  1. change in temperature before and end of operation

    Time frame: on arrival at the OR upto 1-2hours after induction (at the end of the operation)

    change in core temperature will be calculated and compared

  2. incidence of shivering

    Time frame: upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)

    shivering will be evaluated using 4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body)

  3. thermal comfort

    Time frame: upto 1hour after end of the operation (at discharge of postanesthesia care unit)

    thermal comfort will be evaluated using thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable)

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Effect of 10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery Under General Anesthesia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
Nov 25, 2022

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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