Procedural AnxietyREMI-SENNCT05415202
Remimazolam Sedation for Nerve Blocks
An observational study of Procedural Anxiety and Procedural Pain, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Procedural Anxiety, Procedural Pain
- What is being tested?
- Remimazolam 20 MG [Byfavo]
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be identified by providers and study personnel according to inclusion and exclusion criteria by reviewing electronic charts of patients who will be receiving nerve blocks. Once identified as a possible pre-op block or re-block, then the patients will be approached and asked if they wish to participate in the study. Patient will be screened by chart review and questioning for allergies to remimazolam or dextran 40 and will be excluded if allergy is present.
Who may be able to join
- Age greater than or equal to 18 years.
- 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.
Who cannot join
- Age less than 18 years.
- Clinical instability or other condition preventing nerve block or sedation.
- Pregnancy.
- Inability to communicate quickly and efficiently their level of perceived sedation.
- Allergy to remimazolam or dextran 40.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remimazolam Safety and Efficacy for Nerve Blocks
Observational study recording sedation and safety of patients undergoing remimazolam sedation for peripheral nerve blocks.
Objectives:
Read more
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.
Read the detailed description
Nerve blocks are short, mildly stimulating procedures that result in no increase in pain post-procedurally. They are often performed at our institution with sedation, typically midazolam with or without fentanyl.
Remimazolam is an intravenous sedative agent FDA approved for procedural sedation.
Remimazolam is an intravenous sedative agent FDA approved for procedural sedation. It has been shown to be safe and effective in outpatient colonoscopy and has demonstrated a faster recovery to neuropsychiatric function compared to midazolam.[i] It also has demonstrated decreased rates of hypotension and faster recovery time when compared to midazolam.i For high risk colonoscopies, similar rates of bradycardia and blood pressure changes have been found; and remimazolam was shown to be safe and short acting.[ii] For bronchoscopies, remimazolam continues to demonstrate faster return to neuropsychiatric function when compared to midazolam, as well as a safety profile equivalent to midazolam.[iii]
With a safety profile equivalent to midazolam but a much shorter duration of effect, it is a natural choice for a short, mildly stimulating procedures such as nerve blocks.
Patients will be identified by providers and study personnel according to inclusion and exclusion criteria by reviewing electronic charts of patients who will be receiving nerve blocks. Once identified as a possible pre-op block or re-block, then the patients will be approached and asked if they wish to participate in the study. Patient will be screened by chart review and questioning for allergies to remimazolam or dextran 40 and will be excluded if allergy is present.
After patients are identified by providers or study personnel as meeting the inclusion/exclusion criteria on the day of surgery, they will be approached and asked if they wish to participate in the study. If they choose to participate, then a provider or study personnel will perform the informed consent process.
BYFAVO (remimazolam) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. For this study, remimazolam will be used according to its FDA approval, for procedural sedation in adults undergoing procedures lasting 30 minutes or less: peripheral nerve blocks, catheters, plane blocks, or epidural procedures. Route: Intravenous.
The nerve block will then be performed under standard conditions with standard monitors. Remimazolam will be used for sedation following the guidelines on the label.
Dosing will be as follows:
Induction of Procedural Sedation For adult patients: Administer 5 mg intravenously over a 1-minute time period. For ASA* III and IV patients: Administer 2.5 mg to 5 mg intravenously over 1 minute based on the general condition of the patient.
Maintenance of Procedural Sedation (as needed) For adult patients: Administer 2.5 mg intravenously over 15 seconds. At least 2 minutes must elapse prior to administration of any supplemental dose.
For ASA III and IV patients: Administer 1.25 mg to 2.5 mg intravenously over 15 seconds.
At least 2 minutes must elapse prior to administration of any supplemental dose.
MOASS scores will be assessed at baseline and frequently until 3 consecutive 5's are observed. The patient will be monitored until they have scored three consecutive 5's on the MOASS scale and their vital signs are stable. Any additional required sedative medications will be recorded, as will vital signs and side effects.
Supplemental oxygen may be administered as needed.
Patients are not eligible to participate in the study more than once.
[i] Rex, D. K., Bhandari, R., Desta, T., DeMicco, M. P., Schaeffer, C., Etzkorn, K., et al. (2018). A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared with Placebo and Midazolam in Patients Undergoing Colonoscopy. Gastrointest. Endosc. 88 (3), 427-437.e6. doi:10.1016/j.gie.2018.04.2351
[ii] Rex, D. K., Bhandari, R., Lorch, D. G., Meyers, M., Schippers, F., and Bernstein, D. (2021). Safety and Efficacy of Remimazolam in High Risk Colonoscopy: A Randomized Trial. Dig. Liver Dis. 53 (1), 94-101. doi:10.1016/j.dld.2020.10.039
[iii] Pastis, N. J., Yarmus, L. B., Schippers, F., Ostroff, R., Chen, A., Akulian, J., et al. (2019). Safety and Efficacy of Remimazolam Compared with Placebo and Midazolam for Moderate Sedation during Bronchoscopy. Chest 155 (1), 137-146. doi:10.1016/j.chest.2018.09.015
- Conditions
- Procedural Anxiety, Procedural Pain
- Being tested
- Remimazolam 20 MG [Byfavo]
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam 20 MG [Byfavo]Drug
Remimazolam will be administered for sedation and efficacy and safety will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Sedation | Patients receiving a nerve block prior to surgery or a re-block the day after surgery will receive remimazolam sedation for their nerve block.
The nerve block will then be performed under standard conditions with standard monitors. Remimazolam will be used for sedation following the guidelines on the label.
Dosing will be as follows:
Induction of Procedural Sedation For adult patients: Administer 5 mg intravenously over a 1-minute time period. For ASA* III and IV patients: Administer 2.5 mg to 5 mg intravenously over 1 minute based on the general condition of the patient.
Maintenance of Procedural Sedation (as needed) For adult patients: Administer 2.5 mg intravenously over 15 seconds. At least 2 minutes must elapse prior to administration of any supplemental dose.
For ASA III and IV patients: Administer 1.25 mg to 2.5 mg intravenously over 15 seconds.
At least 2 minutes must elapse prior to administration of any supplemental dose. Receives: Drug: Remimazolam 20 MG [Byfavo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (10)
Nerve block completion or abortion
Will record if the nerve block was completed or aborted
Measured: 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)
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.
Measured: 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)
Oxygen Requirement
Oxygen requirement will be recorded. Will include liters per minute of oxygen administered as well as method of delivery.
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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
Measured: 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)
Required hemodynamic intervention
Any required hemodynamic intervention will be recorded including (but not limited to): reversal agent administration, vasoactive substance administration, procedure cancellation
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start6 Jun 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jake Brandenburg, University of Utah
- Investigators
- Jacob Brandenburg, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415202
- Sponsor's protocol ID
- IRB_00149157
- Acronym
- REMI-SEN
- Status last verified
- Sep 2023
- First submitted
- 4 Jun 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29723512Rex 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.
PubMed 33243567Pastis 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.
PubMed 30292760
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam Safety and Efficacy for Nerve Blocks
- ClinicalTrials.gov ID
- NCT05415202
- Acronym / sponsor ID
- REMI-SEN / IRB_00149157
- Conditions
- Procedural Anxiety, Procedural Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nerve blocks are short, mildly stimulating procedures that result in no increase in pain post-procedurally. They are often performed at our institution with sedation, typically midazolam with or without fentanyl.
Remimazolam is an intravenous sedative agent FDA approved for procedural sedation.
Remimazolam is an intravenous sedative agent FDA approved for procedural sedation. It has been shown to be safe and effective in outpatient colonoscopy and has demonstrated a faster recovery to neuropsychiatric function compared to midazolam.[i] It also has demonstrated decreased rates of hypotension and faster recovery time when compared to midazolam.i For high risk colonoscopies, similar rates of bradycardia and blood pressure changes have been found; and remimazolam was shown to be safe and short acting.[ii] For bronchoscopies, remimazolam continues to demonstrate faster return to neuropsychiatric function when compared to midazolam, as well as a safety profile equivalent to midazolam.[iii]
With a safety profile equivalent to midazolam but a much shorter duration of effect, it is a natural choice for a short, mildly stimulating procedures such as nerve blocks.
Patients will be identified by providers and study personnel according to inclusion and exclusion criteria by reviewing electronic charts of patients who will be receiving nerve blocks. Once identified as a possible pre-op block or re-block, then the patients will be approached and asked if they wish to participate in the study. Patient will be screened by chart review and questioning for allergies to remimazolam or dextran 40 and will be excluded if allergy is present.
After patients are identified by providers or study personnel as meeting the inclusion/exclusion criteria on the day of surgery, they will be approached and asked if they wish to participate in the study. If they choose to participate, then a provider or study personnel will perform the informed consent process.
BYFAVO (remimazolam) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. For this study, remimazolam will be used according to its FDA approval, for procedural sedation in adults undergoing procedures lasting 30 minutes or less: peripheral nerve blocks, catheters, plane blocks, or epidural procedures. Route: Intravenous.
The nerve block will then be performed under standard conditions with standard monitors. Remimazolam will be used for sedation following the guidelines on the label.
Dosing will be as follows:
Induction of Procedural Sedation For adult patients: Administer 5 mg intravenously over a 1-minute time period. For ASA* III and IV patients: Administer 2.5 mg to 5 mg intravenously over 1 minute based on the general condition of the patient.
Maintenance of Procedural Sedation (as needed) For adult patients: Administer 2.5 mg intravenously over 15 seconds. At least 2 minutes must elapse prior to administration of any supplemental dose.
For ASA III and IV patients: Administer 1.25 mg to 2.5 mg intravenously over 15 seconds.
At least 2 minutes must elapse prior to administration of any supplemental dose.
MOASS scores will be assessed at baseline and frequently until 3 consecutive 5's are observed. The patient will be monitored until they have scored three consecutive 5's on the MOASS scale and their vital signs are stable. Any additional required sedative medications will be recorded, as will vital signs and side effects.
Supplemental oxygen may be administered as needed.
Patients are not eligible to participate in the study more than once.
[i] Rex, D. K., Bhandari, R., Desta, T., DeMicco, M. P., Schaeffer, C., Etzkorn, K., et al. (2018). A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared with Placebo and Midazolam in Patients Undergoing Colonoscopy. Gastrointest. Endosc. 88 (3), 427-437.e6. doi:10.1016/j.gie.2018.04.2351
[ii] Rex, D. K., Bhandari, R., Lorch, D. G., Meyers, M., Schippers, F., and Bernstein, D. (2021). Safety and Efficacy of Remimazolam in High Risk Colonoscopy: A Randomized Trial. Dig. Liver Dis. 53 (1), 94-101. doi:10.1016/j.dld.2020.10.039
[iii] Pastis, N. J., Yarmus, L. B., Schippers, F., Ostroff, R., Chen, A., Akulian, J., et al. (2019). Safety and Efficacy of Remimazolam Compared with Placebo and Midazolam for Moderate Sedation during Bronchoscopy. Chest 155 (1), 137-146. doi:10.1016/j.chest.2018.09.015
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Sedation | – | Drug: Remimazolam 20 MG [Byfavo]Patients receiving a nerve block prior to surgery or a re-block the day after surgery will receive remimazolam sedation for their nerve block. The nerve block will then be performed under standard conditions with standard monitors. Remimazolam will be used for sedation following the guidelines on the label. Dosing will be as follows: Induction of Procedural Sedation For adult patients: Administer 5 mg intravenously over a 1-minute time period. For ASA* III and IV patients: Administer 2.5 mg to 5 mg intravenously over 1 minute based on the general condition of the patient. Maintenance of Procedural Sedation (as needed) For adult patients: Administer 2.5 mg intravenously over 15 seconds. At least 2 minutes must elapse prior to administration of any supplemental dose. For ASA III and IV patients: Administer 1.25 mg to 2.5 mg intravenously over 15 seconds. At least 2 minutes must elapse prior to administration of any supplemental dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified by providers and study personnel according to inclusion and exclusion criteria by reviewing electronic charts of patients who will be receiving nerve blocks. Once identified as a possible pre-op block or re-block, then the patients will be approached and asked if they wish to participate in the study. Patient will be screened by chart review and questioning for allergies to remimazolam or dextran 40 and will be excluded if allergy is present.
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years.
- 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.
Key exclusion criteria (5 listed)
- Age less than 18 years.
- Clinical instability or other condition preventing nerve block or sedation.
- Pregnancy.
- Inability to communicate quickly and efficiently their level of perceived sedation.
- Allergy to remimazolam or dextran 40.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam 20 MG [Byfavo]Remimazolam will be administered for sedation and efficacy and safety will be recorded | Drug | Remimazolam Sedation |
Primary outcome
Change during procedure in Modified Observer's Assessment of Alertness/Sedation Scale score
Time frame: 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)
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.
10 secondary outcomes
Nerve block completion or abortion
Time frame: 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)
Additional sedative requirement
Time frame: 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)
Oxygen Requirement
Time frame: 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)
Change in oxygen saturation as measured by pulse oximetry
Time frame: 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)
Change in systolic blood pressure
Time frame: 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)
Change in diastolic blood pressure
Time frame: 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)
Change in mean arterial blood pressure
Time frame: 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)
Change in Heart Rate
Time frame: 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)
Required airway intervention
Time frame: 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)
Required hemodynamic intervention
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 29723512Rex 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.
- Background: PubMed 33243567Rex 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.
- Background: PubMed 30292760Pastis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Brandenburg, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedural Anxiety and Procedural Pain, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change during procedure in Modified Observer's Assessment of Alertness/Sedation Scale score (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415202, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.