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No longer clinically relevant
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This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose dexmedetomidine | Experimental | Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min |
|
| Low dose dexmedetomidine | Active Comparator | Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients With Monitorable of Motor Evoked Potentials | Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less. | During a single surgery for the duration of the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Emerson, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Dexmedetomidine | Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery. |
| FG001 | Highdose Dexmedetomidine | Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Dexmedetomidine | Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery. |
| BG001 | Low Dose Dexmedetomidine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients With Monitorable of Motor Evoked Potentials | Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less. | Posted | Count of Participants | Participants | During a single surgery for the duration of the operation |
|
From time of consent through the duration of surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Dexmedetomidine | Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Emerson, MD | Hospital for Special Surgery | 2127742742 | emersonr@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2017 | Feb 11, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2017 | Mar 6, 2020 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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The anesthesiologist administering anesthetic agents will have knowledge of their doses. The technologist performing motor evoked potential testing and other participants will not.
|
Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | High Dose Dexmedetomidine | Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery. | 0 | 3 | 0 | 3 | 0 | 3 |
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