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CompletedNCT05760534Updated Dec 29, 2025

Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia

A Phase 4 interventional study of Remimazolam in Arthritis Knee and Arthritis Hip, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
19 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Arthritis Knee
  • Arthritis Hip
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

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

04

Who can participate

Ages eligible
19 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Ideal body weight group

    Drug: Remimazolam

  • Active comparator
    Total body weight group

    Drug: Remimazolam

Interventions

  • DrugRemimazolam

    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

06

What researchers measure

Primary outcomes

  1. Incidence of intraoperative respiratory depression

    Incidence of intraoperative respiratory depression

    Time frame: From entrance to exit from the operating room

Secondary outcomes

  1. Total remimazolam infusion dose

    Total remimazolam infusion dose (mg/kg/h)

    Time frame: From start to end of remimazolam infusion

  2. Incidence of intraoperative hypotension

    Mean blood pressure \<65 mmHg

    Time frame: From entrance to exit from the operating room

  3. Incidence of intraoperative hypertension

    Systolic blood pressure \>120% of baseline

    Time frame: From entrance to exit from the operating room

  4. Incidence of intraoperative bradycardia

    Heart rate \<45 bpm

    Time frame: From entrance to exit from the operating room

  5. Incidence of intraoperative tachycardia

    Heart rate \>120 bpm

    Time frame: From entrance to exit from the operating room

  6. Incidence of intraoperative oxygen desaturation

    Pulse oximeter saturation (SpO2) \< 93%

    Time frame: From entrance to exit from the operating room

  7. Incidence of intraoperative nausea or vomiting

    Nausea or vomiting during surgery

    Time frame: From entrance to exit from the operating room

  8. Incidence of intraoperative hiccups

    Hiccups during surgery

    Time frame: From entrance to exit from the operating room

  9. Incidence of intraoperative paradoxical movements

    Paradoxical movements during surgery

    Time frame: From entrance to exit from the operating room

  10. Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score

    MOAA/S score assessment at 10 min intervals

    Time frame: From start of remimazolam infusion until time of full alertness

  11. Intraoperative Patient State Index (PSi)

    Continuous monitoring of PSi with Sedline sensor

    Time frame: From entrance to exit from the operating room

  12. Time to reach MOAA/S score 5 after end of surgery

    Time to reach MOAA/S score 5 (min)

    Time frame: From end of remimazolam infusion until time of full alertness

  13. Length of stay at the post-anesthesia care unit (PACU)

    Length of stay at the PACU (min)

    Time frame: From entrance to exit from the PACU

  14. Patient satisfaction

    Numeric rating scale of 0 (not satisfied at all) to 10 (absolutely satisfied)

    Time frame: At exit from PACU

  15. Intraoperative recall

    Assessment with the modified Brice questionnaire

    Time frame: At exit from PACU

  16. Incidence of postoperative nausea or vomiting

    Incidence of nausea or vomiting

    Time frame: From entrance to exit from the PACU

  17. Incidence of postoperative delirium

    Assessment with the Confusion Assessment Method (CAM)

    Time frame: From end of surgery to third postoperative day

  18. Incidence of postoperative respiratory depression

    Respiratory rate \< 8/min or SpO2\<93%

    Time frame: From entrance to exit from the PACU

  19. Incidence of postoperative hypotension

    Mean blood pressure \<65 mmHg

    Time frame: From entrance to exit from the PACU

  20. Incidence of postoperative hypertension

    Systolic blood pressure \>120% from baseline

    Time frame: From entrance to exit from the PACU

07

Study locations

1 site
  • Jin-Tae Kim
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05760534
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 8, 2023
Start date
Mar 6, 2023
Primary completion
Nov 25, 2025
Completion
Nov 25, 2025
Last update
Dec 29, 2025

Study contacts

Jin-Tae Kim, M.D., Ph.D.
principal investigator · Seoul National University Hospital

Oversight

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

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

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