Temperature Change, BodyNCT06853067
Effect of Dexmedetomidine and Remimazolam on Body Temperature in Patients Undergoing Spinal Anesthesia
A study testing Monitoring of body temperature in people with Temperature Change, Body, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
This study aims to evaluate the effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Monitoring of body temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2025to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective surgery under spinal anesthesia
Who cannot join
- Severe vascular disease
- Thyroid dysfunction
- Coagulopathy
- Neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
SMG-SNU Boramae Medical Center
Seoul, Select State/Province, 07061
About this study
This study aims to evaluate the effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia.
- Conditions
- Temperature Change, Body
- Being tested
- Monitoring of body temperature
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of body temperatureOther
Body temperature is monitored in the forehead using the Temperature Monitoring Patient Sensors in patients sedated with dexmedetomidine or remimazolam during spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Dexmedetomidine is administered for sedation in patients undergoing spinal anesthesia Receives: Other: Monitoring of body temperature |
| Remimazolam group | Experimental | Remimazolam is administered for sedation in patients undergoing spinal anesthesia Receives: Other: Monitoring of body temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypothermia during surgery
Incidence of temperature <36℃ during spinal anesthesia is assessed.
Measured: Body temperature is monitored during surgery
Secondary outcomes (2)
Incidence of hypothermia in the post-anesthesia recovery room
Body temperature is assessed in the in the post-anesthesia recovery room
Measured: Immediately after entering the the post-anesthesia recovery room, until the discharge
Incidence of shivering during surgery and in the post-anesthesia recovery room
Occurrence of shivering is assessed.
Measured: During surgery and in the post-anesthesia recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start15 Apr 2025
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853067
- Sponsor's protocol ID
- 20240701
- Status last verified
- Sep 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine and Remimazolam on Body Temperature in Patients Undergoing Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06853067
- Acronym / sponsor ID
- 20240701
- Conditions
- Temperature Change, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Other: Monitoring of body temperatureDexmedetomidine is administered for sedation in patients undergoing spinal anesthesia |
| Remimazolam group | Experimental | Other: Monitoring of body temperatureRemimazolam is administered for sedation in patients undergoing spinal anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective surgery under spinal anesthesia
Key exclusion criteria (4 listed)
- Severe vascular disease
- Thyroid dysfunction
- Coagulopathy
- Neuromuscular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of body temperatureBody temperature is monitored in the forehead using the Temperature Monitoring Patient Sensors in patients sedated with dexmedetomidine or remimazolam during spinal anesthesia. | Other | Dexmedetomidine group, Remimazolam group |
Primary outcome
Incidence of hypothermia during surgery
Time frame: Body temperature is monitored during surgery
Incidence of temperature <36℃ during spinal anesthesia is assessed.
2 secondary outcomes
Incidence of hypothermia in the post-anesthesia recovery room
Time frame: Immediately after entering the the post-anesthesia recovery room, until the discharge
Incidence of shivering during surgery and in the post-anesthesia recovery room
Time frame: During surgery and in the post-anesthesia recovery room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of body temperature in people with Temperature Change, Body, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypothermia during surgery (time frame: Body temperature is monitored during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.