Clinical trial

Remimazolam Safety and Efficacy for Nerve Blocks

Name

IRB_00149157

Description

Observational study recording sedation and safety of patients undergoing remimazolam sedation for peripheral nerve blocks. Objectives: To explore the safety and efficacy of remimazolam for neuraxial procedures and peripheral nerve pre-blocks and re-blocks. Patients undergoing epidurals, fascial plane blocks, and peripheral nerve blocks will receive remimazolam for sedation. Specific outcomes to assess include: depth of sedation, length of sedation, presence of apnea, presence of nausea/vomiting/other side effects, if the sedation was sufficient for the procedure. Assessment methods: MOAAS - Modified Observer's Assessment of Alertness and Sedation score Subjective patient report Vital signs Time for recovery Side effects Hypothesis: Remimazolam provides short-acting, adequate and safe sedation for peripheral nerve blocks in the ambulatory setting.

Trial arms

Trial start

2022-06-06

Estimated PCD

2022-08-01

Trial end

2022-08-01

Status

Completed

Treatment

Remimazolam 20 MG [Byfavo]

Remimazolam will be administered for sedation and efficacy and safety will be recorded

Arms:

Remimazolam Sedation

Size

100

Primary endpoint

Change during procedure in Modified Observer's Assessment of Alertness/Sedation Scale score

Each minute during procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes)

Eligibility criteria

Inclusion Criteria: 1. Age greater than or equal to 18 years. 2. Will be receiving a pre-operative nerve block (single shot nerve block, nerve block catheter, plane block, epidural, etc.) or a re-block (a nerve block performed for pain control at least one day after surgery) from a qualified APS team member. Exclusion Criteria: 1. Age less than 18 years. 2. Clinical instability or other condition preventing nerve block or sedation. 3. Pregnancy. 4. Inability to communicate quickly and efficiently their level of perceived sedation. 5. Allergy to remimazolam or dextran 40.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

Updated at

2023-09-28

1 organization

1 product

2 indications

Organization

Product

Indication

Indication