Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation
1 other identifier
interventional
104
1 country
1
Brief Summary
The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedStudy Start
First participant enrolled
July 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2022
CompletedNovember 29, 2022
November 1, 2022
4 months
June 21, 2022
November 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of rescue sedative doses administered
Intraoperative period
Secondary Outcomes (16)
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
- +11 more secondary outcomes
Study Arms (2)
Remimazolam
ACTIVE COMPARATORDexmedetomidine
ACTIVE COMPARATORInterventions
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5\~1.0 mg/kg/h continuous infusion
1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\~0.7 mcg/kg/h continuous infusion
Eligibility Criteria
You may qualify if:
- Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Jongno-gu, 03080, South Korea
Related Publications (1)
Kim H, Kim Y, Bae J, Yoo S, Lim YJ, Kim JT. Comparison of remimazolam and dexmedetomidine for intraoperative sedation in patients undergoing lower extremity surgery under spinal anesthesia: a randomized clinical trial. Reg Anesth Pain Med. 2024 Feb 5;49(2):110-116. doi: 10.1136/rapm-2023-104415.
PMID: 37280081DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 21, 2022
First Posted
July 7, 2022
Study Start
July 8, 2022
Primary Completion
October 26, 2022
Study Completion
October 26, 2022
Last Updated
November 29, 2022
Record last verified: 2022-11