Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Phase 4

Completed

• Conditions: Orthopedic Disorder
• Interventions: Drug: Remimazolam; Drug: Dexmedetomidine

• Registration Number: NCT05447507
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-07
• Study Start: 2022-07-08
• Primary Completion: 2022-10-26
• Study Completion: 2022-10-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	Remimazolam	-
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Number of rescue sedative doses administered	Intraoperative period

Secondary Outcome Measures

Name	Time	Method
Postoperative spinal anesthesia block level	Postoperative period, up to 12h hours after end of surgery
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)
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	0 Not at all satisfied, 10 very satisfied
Serum CRP level	Preoperative baseline and second postoperative day

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of