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NCT Number: NCT05636189

Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature.

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

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Key information

Conditions

Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases 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

Hypothermia is of continuous issue in patients undergoing general anesthesia. During urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods including prewarming of the patient are used to maintain core temperature during operation.

Prewarming is found to be effective in maintaining core temperature perioperatively by increasing peripheral tissue heat content. However, applying more than 30 minutes of prewarming may be impractical as a clinical routine practice. Hence, developing simple and effective method to prevent hypothermia is expected.

Here, the investigators planned to examine the effect of active warming (10 minutes of warming during induction of general anesthesia 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
  • previous 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

warming during induction of anesthesia

Procedure

Warming group patients are applied air-forced warming device (bair-hugger 43'C) with blanket (warm touch, COVIDIEN, full body blanket) during induction of anesthesia in the operation room.

Prewarmed intravenous fluid administration

Procedure

Prewarmed intravenous fluid is connected.

Primary outcomes

  1. incidence of hypothermia at the end of the operation

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

    number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded.

Secondary outcomes

  1. change in temperature drop 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 observed

  2. thermal comfort

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

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

  3. incidence of shivering

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

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

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2022
Registry last updated
Aug 30, 2023

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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