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

September 19, 2025 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
This study aims to evaluate the effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled for elective surgery under spinal anesthesia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine group
Dexmedetomidine is administered for sedation in patients undergoing spinal anesthesia
Other: Monitoring 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.
Experimental: Remimazolam group
Remimazolam is administered for sedation in patients undergoing spinal anesthesia
Other: Monitoring 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hypothermia during surgery
Time Frame: Body temperature is monitored during surgery
Incidence of temperature <36℃ during spinal anesthesia is assessed.
Body temperature is monitored during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hypothermia in the post-anesthesia recovery room
Time Frame: Immediately after entering the the post-anesthesia recovery room, until the discharge
Body temperature is assessed in the in the post-anesthesia recovery room
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
Occurrence of shivering is assessed.
During surgery and in the post-anesthesia recovery room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Actual)

August 28, 2025

Study Completion (Actual)

August 28, 2025

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240701

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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