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This is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. They will be followed for approximately six weeks postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV dexmedetomidine | Experimental | Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics. |
|
| Placebo | Placebo Comparator | saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalents Used During the First 48 Hours Post-Surgery | Amount of morphine administered during the 48 hours following surgery. | Up to 48 Hours Post-Surgery (Day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery | The NPRS is a self-assessment of pain. Participants select a number between 0 and 10 that fits best to their pain intensity, where 0 represents 'no pain at all' and 10 represents 'the worst pain ever possible.' | 48 Hours Post-Surgery (Day 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Doan, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Dexmedetomidine | Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics. Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia. |
| FG001 | Placebo | saline placebo Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Dexmedetomidine | Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics. Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Morphine Equivalents Used During the First 48 Hours Post-Surgery | Amount of morphine administered during the 48 hours following surgery. | Posted | Median | Inter-Quartile Range | morphine milligram equivalent (MME) | Up to 48 Hours Post-Surgery (Day 2) |
|
6 weeks following last administration of study treatment
At each contact with the participant, the investigator requested information on adverse events by specific questioning and, as appropriate, by examination.
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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 | IV Dexmedetomidine | Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics. Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Doan, MD | NYU Langone Health | 212.201.1004 | Lisa.Doan@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2021 | Feb 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Placebo Saline | Other | Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia. |
|
| Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery |
The NPRS is a self-assessment of pain. Participants select a number between 0 and 10 that fits best to their pain intensity, where 0 represents 'no pain at all' and 10 represents 'the worst pain ever possible.' |
| Week 6 |
| Morphine Equivalents Used at 6 Weeks Post-Surgery | Amount of morphine administered during the 6 weeks following surgery. | Up to Week 6 |
| Number of Participants Requiring Pressor Use During Intraoperative Period | The intraoperative period begins when the patient is transferred to the operating room table and ends with the transfer of a patient to the Post Anesthesia Care Unit (PACU). | From beginning up to end of surgery (Day 0 - typically 1 to 3 hours) |
| Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery | Up to 48 Hours Post-Surgery (Day 2) |
| Length of PACU Stay | From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours) |
| Length of Hospital Stay | From admission up to discharge (Up to 6 Weeks) |
| Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery | The QoR-15 is a 15-item self measurement of patients' overall satisfaction with postoperative recovery. Items are ranked on a Likert scale of 0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]. Higher scores indicate greater satisfaction with postoperative recovery. The total score ranges from 0 to 150; higher scores indicate greater satisfaction with postoperative recovery. | 48 Hours Post-Surgery (Day 2) |
| Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery | The QoR-15 is a 15-item self measurement of patients' overall satisfaction with postoperative recovery. Items are ranked on a Likert scale of 0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]. Higher scores indicate greater satisfaction with postoperative recovery. The total score ranges from 0 to 150; higher scores indicate greater satisfaction with postoperative recovery. | Week 6 |
| Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery | The SF-MPQ is a self-assessment of pain symptoms. The questionnaire includes 15 pain descriptor items that are ranked on a Likert scale from 0 (none) to 3 (severe); one Visual Analogue Scale (VAS) item on which participants rank pain on a 10 cm VAS; and one Present Pain Intensity item on which participants rank their present pain on a Likert scale from 0 (no pain) to 5 (excruciating). The total score is the sum of responses and ranges from 0-60; lower scores indicate less pain. The SF-MPQ is administered on postoperative days 1 and 2. | 48 Hours Post-Surgery (Day 2) |
| Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery | The SF-MPQ is a self-assessment of pain symptoms. The questionnaire includes 15 pain descriptor items that are ranked on a Likert scale from 0 (none) to 3 (severe); one Visual Analogue Scale item on which participants rank pain on a 10 cm VAS; and one Present Pain Intensity item on which participants rank their present pain on a Likert scale from 0 (no pain) to 5 (excruciating). The total score is the sum of responses and ranges from 0-60; lower scores indicate less pain. | Week 6 |
| BG001 |
| Placebo |
saline placebo Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery | The NPRS is a self-assessment of pain. Participants select a number between 0 and 10 that fits best to their pain intensity, where 0 represents 'no pain at all' and 10 represents 'the worst pain ever possible.' | Posted | Mean | Standard Deviation | score on a scale | 48 Hours Post-Surgery (Day 2) |
|
|
|
| Secondary | Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery | The NPRS is a self-assessment of pain. Participants select a number between 0 and 10 that fits best to their pain intensity, where 0 represents 'no pain at all' and 10 represents 'the worst pain ever possible.' | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
|
| Secondary | Morphine Equivalents Used at 6 Weeks Post-Surgery | Amount of morphine administered during the 6 weeks following surgery. | Posted | Median | Inter-Quartile Range | morphine milligram equivalent (MME) | Up to Week 6 |
|
|
|
| Secondary | Number of Participants Requiring Pressor Use During Intraoperative Period | The intraoperative period begins when the patient is transferred to the operating room table and ends with the transfer of a patient to the Post Anesthesia Care Unit (PACU). | Posted | Count of Participants | Participants | From beginning up to end of surgery (Day 0 - typically 1 to 3 hours) |
|
|
|
| Secondary | Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery | Posted | Count of Participants | Participants | Up to 48 Hours Post-Surgery (Day 2) |
|
|
|
| Secondary | Length of PACU Stay | Posted | Mean | Standard Deviation | minutes | From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours) |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Mean | Standard Deviation | Days | From admission up to discharge (Up to 6 Weeks) |
|
|
|
| Secondary | Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery | The QoR-15 is a 15-item self measurement of patients' overall satisfaction with postoperative recovery. Items are ranked on a Likert scale of 0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]. Higher scores indicate greater satisfaction with postoperative recovery. The total score ranges from 0 to 150; higher scores indicate greater satisfaction with postoperative recovery. | Posted | Mean | Standard Deviation | score on a scale | 48 Hours Post-Surgery (Day 2) |
|
|
|
| Secondary | Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery | The QoR-15 is a 15-item self measurement of patients' overall satisfaction with postoperative recovery. Items are ranked on a Likert scale of 0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]. Higher scores indicate greater satisfaction with postoperative recovery. The total score ranges from 0 to 150; higher scores indicate greater satisfaction with postoperative recovery. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
|
| Secondary | Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery | The SF-MPQ is a self-assessment of pain symptoms. The questionnaire includes 15 pain descriptor items that are ranked on a Likert scale from 0 (none) to 3 (severe); one Visual Analogue Scale (VAS) item on which participants rank pain on a 10 cm VAS; and one Present Pain Intensity item on which participants rank their present pain on a Likert scale from 0 (no pain) to 5 (excruciating). The total score is the sum of responses and ranges from 0-60; lower scores indicate less pain. The SF-MPQ is administered on postoperative days 1 and 2. | Posted | Mean | Standard Deviation | score on a scale | 48 Hours Post-Surgery (Day 2) |
|
|
|
| Secondary | Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery | The SF-MPQ is a self-assessment of pain symptoms. The questionnaire includes 15 pain descriptor items that are ranked on a Likert scale from 0 (none) to 3 (severe); one Visual Analogue Scale item on which participants rank pain on a 10 cm VAS; and one Present Pain Intensity item on which participants rank their present pain on a Likert scale from 0 (no pain) to 5 (excruciating). The total score is the sum of responses and ranges from 0-60; lower scores indicate less pain. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
|
|
|
| 1 |
| 33 |
| 0 |
| 33 |
| 1 |
| 33 |
| EG001 | Placebo | saline placebo Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia. | 0 | 31 | 0 | 31 | 2 | 31 |
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
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