ClinicalTrials.gg
CompletedNCT06853067Updated Sep 24, 2025

Effect of Dexmedetomidine and Remimazolam on Body Temperature in Patients Undergoing Spinal Anesthesia

An interventional study of Monitoring of body temperature in Temperature Change, Body, sponsored by SMG-SNU Boramae Medical Center. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by SMG-SNU Boramae Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This study aims to evaluate the effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia.

02

Conditions studied

  • Temperature Change, Body
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 122 is above the median of 40 across 68 interventional studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

SMG-SNU Boramae Medical Center is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients scheduled for elective surgery under spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • Severe vascular disease
  • Thyroid dysfunction
  • Coagulopathy
  • Neuromuscular disease.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    Dexmedetomidine group

    Dexmedetomidine is administered for sedation in patients undergoing spinal anesthesia

    Other: Monitoring of body temperature

  • Experimental
    Remimazolam group

    Remimazolam is administered for sedation in patients undergoing spinal anesthesia

    Other: Monitoring of body temperature

Interventions

  • OtherMonitoring of body temperature

    Body temperature is monitored in the forehead using the Temperature Monitoring Patient Sensors in patients sedated with dexmedetomidine or remimazolam during spinal anesthesia.

06

What researchers measure

Primary outcomes

  1. Incidence of hypothermia during surgery

    Incidence of temperature \<36℃ during spinal anesthesia is assessed.

    Time frame: Body temperature is monitored during surgery

Secondary outcomes

  1. Incidence of hypothermia in the post-anesthesia recovery room

    Body temperature is assessed in the in the post-anesthesia recovery room

    Time frame: Immediately after entering the the post-anesthesia recovery room, until the discharge

  2. Incidence of shivering during surgery and in the post-anesthesia recovery room

    Occurrence of shivering is assessed.

    Time frame: During surgery and in the post-anesthesia recovery room

07

Study locations

1 site
  • SMG-SNU Boramae Medical Center
    Seoul, Select State/Province 07061, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06853067
Lead sponsor
SMG-SNU Boramae Medical Center
Responsible party
Jin-Young Hwang (MD., PhD, SMG-SNU Boramae Medical Center) — Principal investigator
First posted
Feb 28, 2025
Start date
Apr 15, 2025
Primary completion
Aug 28, 2025
Completion
Aug 28, 2025
Last update
Sep 24, 2025

Oversight

Data monitoring committee
Yes
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 Sep 2025. You cannot join it, but the record below documents what was studied.

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