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CompletedNCT05651399Updated Feb 26, 2025

Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery

A Phase 4 interventional study of Remimazolam and Propofol in Remimazolam, Propofol and Orthopedic Procedures, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Asan Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study summary

The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.

02

Conditions studied

  • Remimazolam
  • Propofol
  • Orthopedic Procedures
  • Sedatives
  • Anesthesia, Spinal

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 78 is close to the median of 80 across 675 interventional studies indexed under Hypotension.

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Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA physical status 1-3
  • Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam

Exclusion criteria

Exclusion Criteria:

  • Patients who refuse to participate in this study
  • Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease
  • Patients with an allergy to propofol, fentanyl, or bupivacaine
  • Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region
  • Patients judged to be inappropriate for this study
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
78 participants (actual)

Study arms

  • Active comparator
    Remimazolam

    A maintenance dose of remimazolam is administered for sedation

    Drug: Remimazolam

  • Active comparator
    Propofol

    A maintenance dose of propofol is administered for sedation

    Drug: Propofol

Interventions

  • DrugRemimazolam

    Patients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery.

  • DrugPropofol

    Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.

06

What researchers measure

Primary outcomes

  1. Frequency of hypotension during surgery (1hour)

    mean blood pressure less than 65mmHg

    Time frame: up to 1 hour after initiation of drug infusion

Secondary outcomes

  1. Frequency of hypotension during surgery

    mean blood pressure less than 65mmHg

    Time frame: Throughout the surgery

  2. Total administered phenylephrine

    total dose of phenylephrine administered during surgery

    Time frame: Throughout the surgery

  3. Fluid volume

    Total amount of fluid infused during surgery

    Time frame: Throughout the surgery

  4. Number of hypotensive episodes in the post-anesthesia care unit after surgery

    mean blood pressure less than 65mmHg

    Time frame: up to 1 hour after postanesthesia care unit entry

  5. Complications after surgery

    Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting

    Time frame: up to 7 days after surgery

07

Study locations

1 site
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05651399
Lead sponsor
Asan Medical Center
Responsible party
Hajung Kim (Clinical assistant professor, Asan Medical Center) — Principal investigator
First posted
Dec 15, 2022
Start date
Dec 26, 2022
Primary completion
Jun 14, 2023
Completion
Jun 14, 2023
Last update
Feb 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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