Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Orthopedic Disorder Clinical Trial

Official title:

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447507
• Other study ID #: 2205-011-1320
• Status: Completed
• Phase: Phase 4
• Start date: July 8, 2022
• Est. completion date: October 26, 2022

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 26, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Drug:
• Remimazolam
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5~1.0 mg/kg/h continuous infusion
• Dexmedetomidine
1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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