Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block

Seoul National University Hospital1 site in 1 country104 target enrollmentJuly 8, 2022

ConditionsOrthopedic Disorder

InterventionsRemimazolam Dexmedetomidine

DrugsRemimazolam Dexmedetomidine

Overview

Phase: Phase 4
Intervention: Remimazolam
Conditions: Orthopedic Disorder
Sponsor: Seoul National University Hospital
Enrollment: 104
Locations: 1
Primary Endpoint: Number of rescue sedative doses administered
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 8, 2022

End Date

October 26, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin-Tae Kim

Professor

Seoul National University Hospital

Eligibility Criteria

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

Arms & Interventions

Remimazolam

Intervention: Remimazolam

Dexmedetomidine

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

Number of rescue sedative doses administered

Time Frame: Intraoperative period

Secondary Outcomes

Incidence of intraoperative bradycardia (heart rate lower than 45 bpm)(Intraoperative period)
Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline)(Intraoperative period)
Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline)(Intraoperative period)
Incidence of respiratory depression (respiratory rate lower than 8 per minute)(Intraoperative period)
Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%)(Intraoperative period)
MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert)(Intraoperative period)
Intraoperative PSi (Patient State index)(Intraoperative period)
Electroencephalogram data (alpha, beta, delta, theta waves)(Intraoperative period)
Time to reach MOAA/S = 5 after end of drug infusion(Intraoperative period and post-anesthesia care period (immediate post-operative period))
Oxygen supply at the post-anesthesia care unit(Post-anesthesia care period (immediate post-operative period))
Incidence of postoperative delirium(Immediately after the surgery, up to 5 days after surgery)
Incidence of nausea/vomiting(Intraoperative period and post-anesthesia care period (immediate post-operative period))
Postoperative spinal anesthesia block level(Postoperative period, up to 12h hours after end of surgery)
Duration of stay in the post-anesthsia care unit(PACU)(Immediate postoperative period)
Patient satisfaction (numerical rating scale of 0~10)(Immediately after the surgery, up to 5 days after surgery)
Serum CRP level(Preoperative baseline and second postoperative day)