NCT06853067

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

February 18, 2025

Last Update Submit

September 19, 2025

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypothermia during surgery

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

    Body temperature is monitored during surgery

Secondary Outcomes (2)

  • Incidence of hypothermia 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

    During surgery and in the post-anesthesia recovery room

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine is administered for sedation in patients undergoing spinal anesthesia

Other: Monitoring of body temperature

Remimazolam group

EXPERIMENTAL

Remimazolam is administered for sedation in patients undergoing spinal anesthesia

Other: Monitoring of body temperature

Interventions

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.

Dexmedetomidine groupRemimazolam group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective surgery under spinal anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, Select State/Province, 07061, South Korea

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD., PhD

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 28, 2025

Study Start

April 15, 2025

Primary Completion

August 28, 2025

Study Completion

August 28, 2025

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations

KR(1)