NCT05935657

Brief Summary

The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

June 28, 2023

Last Update Submit

August 4, 2023

Conditions

RemimazolamSpinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative hypotension

    mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline

    Intraoperative period

Secondary Outcomes (6)

  • Incidence of intraoperative bradycardia

    Intraoperative period

  • Incidence of intraoperative hypertension

    Intraoperative period

  • Incidence of respiratory depression

    Intraoperative period

  • Incidence of hypoxia

    Intraoperative period

  • Intraoperative Ramsay sedation scale

    Intraoperative period

  • +1 more secondary outcomes

Study Arms (2)

Remimazolam Group

EXPERIMENTAL

sedation with remimazolam

Drug: Remimazolam

Dexmedetomidine group

ACTIVE COMPARATOR

sedation with dexmedetomidine

Drug: Dexmedetomidine

Interventions

RemimazolamDRUG

0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1\~1.0 mg/kg/h continuous infusion

Also known as: Byfavo
Remimazolam Group
DexmedetomidineDRUG

1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\~0.7 mcg/kg/h continuous infusion

Also known as: Precedex
Dexmedetomidine group

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III

You may not qualify if:

  • Patient refusal
  • Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis)
  • Contraindications or allergy to dexmedetomidine or remimazolam administration
  • Emergency surgery
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

remimazolamDexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gyengjo Byeon, PhD

    Pusan National University Yangsan Hospital

    STUDY DIRECTOR

Central Study Contacts

Jieun Jung, MD

CONTACT

820553602129jungje0308@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor for fund

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 7, 2023

Study Start

August 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

August 8, 2023

Record last verified: 2023-08