NCT05760534

Brief Summary

This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2023

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

February 26, 2023

Last Update Submit

December 21, 2025

Conditions

Arthritis KneeArthritis Hip

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative respiratory depression

    Incidence of intraoperative respiratory depression

    From entrance to exit from the operating room

Secondary Outcomes (20)

  • Total remimazolam infusion dose

    From start to end of remimazolam infusion

  • Incidence of intraoperative hypotension

    From entrance to exit from the operating room

  • Incidence of intraoperative hypertension

    From entrance to exit from the operating room

  • Incidence of intraoperative bradycardia

    From entrance to exit from the operating room

  • Incidence of intraoperative tachycardia

    From entrance to exit from the operating room

  • +15 more secondary outcomes

Study Arms (2)

Ideal body weight group

EXPERIMENTAL
Drug: Remimazolam

Total body weight group

ACTIVE COMPARATOR
Drug: Remimazolam

Interventions

RemimazolamDRUG

0.075 mg/kg Remimazolam will be loaded over 1 min, then continuously infused at 0.2-1.0 mg/kg/h based on ideal or total body weight

Ideal body weight groupTotal body weight group

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia
  • BMI\>25
  • American Society of Anesthesiologists (ASA) classification I, II, III

You may not qualify if:

  • Patient refusal
  • Contraindication for spinal anesthesia
  • Contraindication for remimazolam infusion
  • History of hypersensitivity to remimazolam
  • History of chronic use of benzodiazepine or opioid
  • Baseline MOAA/S score of 4 or lower
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

MeSH Terms

Interventions

remimazolam

Study Officials

  • Jin-Tae Kim, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 8, 2023

Study Start

March 6, 2023

Primary Completion

November 25, 2025

Study Completion

November 25, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)