Procedural Pain Clinical Trial
— REMI-SENOfficial title:
Remimazolam Safety and Efficacy for Nerve Blocks
NCT number | NCT05415202 |
Other study ID # | IRB_00149157 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 6, 2022 |
Est. completion date | August 1, 2022 |
Verified date | September 2023 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 1, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4. — View Citation
Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30. — View Citation
Rex DK, Bhandari R, Lorch DG, Meyers M, Schippers F, Bernstein D. Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial. Dig Liver Dis. 2021 Jan;53(1):94-101. doi: 10.1016/j.dld.2020.10.039. Epub 2020 Nov 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change during procedure in Modified Observer's Assessment of Alertness/Sedation Scale score | Sedation efficacy will be measured by serial scores on the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS: 5 is awake and alert, 0 is deep sedation). It will be measured each minute until 3 consecutive 5's are achieved. | 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) | |
Secondary | Nerve block completion or abortion | Will record if the nerve block was completed or aborted | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Additional sedative requirement | Will record if additional sedative medications were required in order to achieve acceptable level of sedation in order to complete the procedure. | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Oxygen Requirement | Oxygen requirement will be recorded. Will include liters per minute of oxygen administered as well as method of delivery. | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Change in oxygen saturation as measured by pulse oximetry | Continuous pulse oximetry will be measured throughout the procedure and recorded every 2.5 minutes from prior to administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Change in systolic blood pressure | Blood pressure will be measured and recorded every 2.5 minutes throughout the procedure from prior to initial administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Change in diastolic blood pressure | Blood pressure will be measured and recorded every 2.5 minutes throughout the procedure from prior to initial administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Change in mean arterial blood pressure | Blood pressure will be measured and recorded every 2.5 minutes throughout the procedure from prior to initial administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Change in Heart Rate | Heart rate will be measured continuously and recorded every 2.5 minutes throughout the procedure from prior to initial administration of remimazolam until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Required airway intervention | Any required airway intervention will be recorded including (but not limited to): intubation, mask ventilation, oral airway, positive pressure ventilation, reversal agent administration, procedure cancellation | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) | |
Secondary | Required hemodynamic intervention | Any required hemodynamic intervention will be recorded including (but not limited to): reversal agent administration, vasoactive substance administration, procedure cancellation | From just prior to initial remimazolam bolus at start of procedure until 3 consecutive 5's on the MOAAS and at least 4 minutes from last administration of medication (up to 30 minutes) |
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