CompletedPhase 4

The Comparison of Remimazolam With Propofol in Core Body Temperature

South Korea90 participantsStarted 2021-03-01

Plain-language summary

1. Core body temperature is normally tightly regulated to within a few tenths of a degree. The major thermoregulatory defences in humans are sweating, arteriovenous shunt vasoconstriction, and shivering. 2. Inadvertent hypothermia often complicates prolonged surgery. In patients becoming sufficiently hypothermic, reemergence of thermoregulatory vasoconstriction usually prevents further core hypothermia. 3. The extent to which anesthetics reduce the vasoconstriction threshold depends on the type of drug and its concentration.

Who can participate

Age range19 Years – 75 Years

SexMALE

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Inclusion criteria

✓. ASA physical classification I-III,
✓. Patients who undergoing Robotic-assisted or laparoscopic (LRP) radical prostatectomy.

Exclusion criteria

✕. Patients who have Medications or any implanted device that could affect cardiovascular function
✕. Patients who have a history with heat imbalance, thyroid diseases, dystautonomia, Raynaud's syndrome, uncontrolled diabetes mellitus, or hypertension.

What they're measuring

core body temperature change (°C)

Timeframe: at 60 minutes after induction of general anesthesia

Trial details

NCT IDNCT05215834

SponsorWonkwang University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Hypothermia; Anesthesia trials