Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block

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

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Drug: Remimazolam; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine	Drug: Dexmedetomidine; 1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion
Active Comparator: Remimazolam	Drug: Remimazolam; 0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5~1.0 mg/kg/h continuous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of rescue sedative doses administered	Intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	0 Not at all satisfied, 10 very satisfied	Immediately after the surgery, up to 5 days after surgery
Serum CRP level		Preoperative baseline and second postoperative day

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 2205-011-1320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No