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Completed

NCT Number: NCT05760534

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

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.

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Key information

Conditions

Arthritis Knee Arthritis Hip

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jin-Tae Kim

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Remimazolam

Drug

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

Primary outcomes

  1. Incidence of intraoperative respiratory depression

    Time frame: From entrance to exit from the operating room

    Incidence of intraoperative respiratory depression

Secondary outcomes

  1. Total remimazolam infusion dose

    Time frame: From start to end of remimazolam infusion

    Total remimazolam infusion dose (mg/kg/h)

  2. Incidence of intraoperative hypotension

    Time frame: From entrance to exit from the operating room

    Mean blood pressure <65 mmHg

  3. Incidence of intraoperative hypertension

    Time frame: From entrance to exit from the operating room

    Systolic blood pressure >120% of baseline

  4. Incidence of intraoperative bradycardia

    Time frame: From entrance to exit from the operating room

    Heart rate <45 bpm

  5. Incidence of intraoperative tachycardia

    Time frame: From entrance to exit from the operating room

    Heart rate >120 bpm

  6. Incidence of intraoperative oxygen desaturation

    Time frame: From entrance to exit from the operating room

    Pulse oximeter saturation (SpO2) < 93%

  7. Incidence of intraoperative nausea or vomiting

    Time frame: From entrance to exit from the operating room

    Nausea or vomiting during surgery

  8. Incidence of intraoperative hiccups

    Time frame: From entrance to exit from the operating room

    Hiccups during surgery

  9. Incidence of intraoperative paradoxical movements

    Time frame: From entrance to exit from the operating room

    Paradoxical movements during surgery

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

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

    MOAA/S score assessment at 10 min intervals

  11. Intraoperative Patient State Index (PSi)

    Time frame: From entrance to exit from the operating room

    Continuous monitoring of PSi with Sedline sensor

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

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

    Time to reach MOAA/S score 5 (min)

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

    Time frame: From entrance to exit from the PACU

    Length of stay at the PACU (min)

  14. Patient satisfaction

    Time frame: At exit from PACU

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

  15. Intraoperative recall

    Time frame: At exit from PACU

    Assessment with the modified Brice questionnaire

  16. Incidence of postoperative nausea or vomiting

    Time frame: From entrance to exit from the PACU

    Incidence of nausea or vomiting

  17. Incidence of postoperative delirium

    Time frame: From end of surgery to third postoperative day

    Assessment with the Confusion Assessment Method (CAM)

  18. Incidence of postoperative respiratory depression

    Time frame: From entrance to exit from the PACU

    Respiratory rate < 8/min or SpO2<93%

  19. Incidence of postoperative hypotension

    Time frame: From entrance to exit from the PACU

    Mean blood pressure <65 mmHg

  20. Incidence of postoperative hypertension

    Time frame: From entrance to exit from the PACU

    Systolic blood pressure >120% from baseline

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia - a Phase 4 Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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