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| ID | Type | Description | Link |
|---|---|---|---|
| OCR18737 | Other Identifier | University of Florida |
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PI left institution.
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This study compares two methods of dosing methadone for complex spine cases
Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dosing of methadone | Active Comparator | Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. |
|
| Aliquots of methadone titrated to apnea | Experimental | Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dosing of methadone | Drug | Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop | The milligram morphine equivalence (MME) dose was computed for each patient in each 24 hour period using IV (intravenous) administration and by mouth (PO). The outcome measure is defined as the difference between 24 hour periods in the cumulative morphine milligram equivalence dose across both IV (intravenous) administration and by mouth (PO). The difference was calculated by subtracting the MME dose value at the later time point minus the MME value at the earlier time point (e.g., value at 24 hours postop minus value at baseline). | Postop 24 hours, Postop 48 hours, Postop 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Seubert, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health | Gainesville | Florida | 32610-3003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20418538 | Result | Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dosing of Methadone | Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. Standard dosing of methadone: Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. |
| FG001 | Aliquots of Methadone Titrated to Apnea | Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed. Aliquots of methadone titrated to apnea: Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dosing of Methadone | Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. Standard dosing of methadone: Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. |
| BG001 |
| 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 | Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop | The milligram morphine equivalence (MME) dose was computed for each patient in each 24 hour period using IV (intravenous) administration and by mouth (PO). The outcome measure is defined as the difference between 24 hour periods in the cumulative morphine milligram equivalence dose across both IV (intravenous) administration and by mouth (PO). The difference was calculated by subtracting the MME dose value at the later time point minus the MME value at the earlier time point (e.g., value at 24 hours postop minus value at baseline). | Posted | Mean | Standard Deviation | milligram morphine equivalence | Postop 24 hours, Postop 48 hours, Postop 72 hours |
|
3 days
Standard definition.
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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 | Standard Dosing of Methadone | Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. Standard dosing of methadone: Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Garvan | University of Florida | 352-870-5403 | cgarvan@ufl.edu |
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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 | May 21, 2024 | Apr 23, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur on the day of surgery. Randomization will be 1:1.
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Post-operative data will be collected by blinded staff. Patient daily pain based on the analog scale of 0-10 post-operative for the first 72 hours, total opioid usage, length of stay, time to get out of bed.
| Aliquots of methadone titrated to apnea | Drug | Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. |
|
| Aliquots of Methadone Titrated to Apnea |
Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed. Aliquots of methadone titrated to apnea: Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Aliquots of Methadone Titrated to Apnea | Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed. Aliquots of methadone titrated to apnea: Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Aliquots of Methadone Titrated to Apnea | Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed. Aliquots of methadone titrated to apnea: Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |