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Completed

NCT Number: NCT05447507

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II.

Exclusion criteria

  • Patient refusal
  • Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy)
  • Contraindications to dexmedetomidine or remimazolam administration
  • Allergy to dexmedetomidine or remimazolam
  • Baseline MOAA/S score of 4 or less
  • Pregnancy
  • Other conditions considered unsuitable by the investigators

Treatment and study plan

Remimazolam

Drug

0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5~1.0 mg/kg/h continuous infusion

Dexmedetomidine

Drug

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

Primary outcomes

  1. Number of rescue sedative doses administered

    Time frame: Intraoperative period

Secondary outcomes

  1. Incidence of intraoperative bradycardia (heart rate lower than 45 bpm)

    Time frame: Intraoperative period

  2. Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline)

    Time frame: Intraoperative period

  3. Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline)

    Time frame: Intraoperative period

  4. Incidence of respiratory depression (respiratory rate lower than 8 per minute)

    Time frame: Intraoperative period

  5. Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%)

    Time frame: Intraoperative period

  6. MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert)

    Time frame: Intraoperative period

  7. Intraoperative PSi (Patient State index)

    Time frame: Intraoperative period

  8. Electroencephalogram data (alpha, beta, delta, theta waves)

    Time frame: Intraoperative period

  9. Time to reach MOAA/S = 5 after end of drug infusion

    Time frame: Intraoperative period and post-anesthesia care period (immediate post-operative period)

  10. Oxygen supply at the post-anesthesia care unit

    Time frame: Post-anesthesia care period (immediate post-operative period)

  11. Incidence of postoperative delirium

    Time frame: Immediately after the surgery, up to 5 days after surgery

  12. Incidence of nausea/vomiting

    Time frame: Intraoperative period and post-anesthesia care period (immediate post-operative period)

  13. Postoperative spinal anesthesia block level

    Time frame: Postoperative period, up to 12h hours after end of surgery

  14. Duration of stay in the post-anesthsia care unit(PACU)

    Time frame: Immediate postoperative period

  15. Patient satisfaction (numerical rating scale of 0~10)

    Time frame: Immediately after the surgery, up to 5 days after surgery

    0 Not at all satisfied, 10 very satisfied

  16. Serum CRP level

    Time frame: Preoperative baseline and second postoperative day

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Nov 29, 2022

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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