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CompletedNCT05636189Updated Aug 30, 2023

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

An interventional study of warming during induction of anesthesia and Prewarmed intravenous fluid administration in Urologic Diseases, sponsored by Inje University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Inje University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Urologic Diseases

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03

In context

Urologic Diseases

193 studies on the registry are indexed under Urologic Diseases; 51 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 135 interventional studies indexed under Urologic Diseases.

Browse Urologic Diseases studies →

Lead sponsor

Inje University is the lead sponsor of 90 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    warming group

    warming of the patient with whole body warming blanket in the OR during induction of anesthesia, prewarmed intravenous fluid during the operation.

    Procedure: warming during induction of anesthesia · Procedure: Prewarmed intravenous fluid administration

  • No intervention
    no warming group

    There will be no whole body warming during induction.

Interventions

  • Procedurewarming during induction of anesthesia

    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.

  • ProcedurePrewarmed intravenous fluid administration

    Prewarmed intravenous fluid is connected.

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What researchers measure

Primary outcomes

  1. incidence of hypothermia at the end of the operation

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

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

Secondary outcomes

  1. change in temperature drop before and end of operation

    change in core temperature will be observed

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

  2. thermal comfort

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

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

  3. incidence of shivering

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

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

07

Study locations

1 site
  • Sanggye paik hospital
    Seoul, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05636189
Lead sponsor
Inje University
Responsible party
In-Jung Jun (assistant professor, Inje University) — Principal investigator
First posted
Dec 5, 2022
Start date
Nov 1, 2022
Primary completion
Aug 8, 2023
Completion
Aug 8, 2023
Last update
Aug 30, 2023

Study contacts

In-Jung Jun, MD, PhD
principal investigator · assistant professor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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