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The main purpose of this study is to determine which type of medication, sufentanil or methadone, is better at controlling pain during and, more importantly, after surgery in patients undergoing a head and neck dissection with free flap or rotational tissue reconstruction. Prior to their operation, subjects will be randomized to receive either Sufentanil or Methadone. After surgery, research staff will obtain information about recovery and pain levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil | Other | 1. Intravenous sufentanil starting at a dose of 0.5 mcg/kg/min hr ideal body weight (IBW) at the beginning of the case, prior to surgical incision, with a discontinuation of the infusion when the surgical microscope is removed from the patient field and the closure of the incision(s) begins. (n=64) |
|
| Methadone | Other | 2. Intravenous methadone of 0.2 mg/kg IBW up to a maximum dose of 20mg, rounded to the nearest milligram. The methadone will be given at the beginning of the case, prior to surgical incision. n=64) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sufentanil | Drug | 1. Intravenous sufentanil starting at a dose of 0.5 mcg/kg/min hr ideal body weight (IBW) at the beginning of the case, prior to surgical incision, with a discontinuation of the infusion when the surgical microscope is removed from the patient field and the closure of the incision(s) begins. (n=64) |
| Measure | Description | Time Frame |
|---|---|---|
| IV morphine equivalent | Cumulative milligrams IV morphine equivalent | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid Consumption and morphine equivalent (MME) | 1 hour after arrival time in post anesthesia care unit |
| Opioid Consumption | Opioid Consumption and morphine equivalent (MME) |
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Inclusion Criteria:
• Patients undergoing head and neck dissection with free flap or rotational reconstruction at Indiana University Health Adult Academic Health Center
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lyla S Farlow | Contact | 317-948-9804 | lychrist@iu.edu | |
| Angie M Plummer | Contact | 317-9447239 | plummera@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gulraj S Chawla, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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A total of 128 subjects will be randomized by a computer program into two groups.
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The Primary investigator or his/her designee will inform the anesthesiology team caring for each subject of the am of the study they are in for each case. Subjects and research staff doing post operative assessments will be blinded to the randomization.
|
| methadone | Drug | 2. Intravenous methadone of 0.2 mg/kg IBW up to a maximum dose of 20mg, rounded to the nearest milligram. The methadone will be given at the beginning of the case, prior to surgical incision. n=64) |
|
| 12 hour after arrival time in post anesthesia care unit |
| Opioid Consumption | Opioid Consumption and morphine equivalent (MME) | 24 hour after arrival time in post anesthesia care unit |
| Pain Scores | Visual analog scale (VAS) pain score on a scale of 1-10 (increments of 1 unit), 1 being no pain at all and 10 being the most pain the patient has ever experienced | 1 hour after arrival time in post anesthesia care unit |
| Pain Scores | Visual analog scale (VAS) pain score on a scale of 1-10 (increments of 1 unit), 1 being no pain at all and 10 being the most pain the patient has ever experienced | 12 hour after arrival time in post anesthesia care unit |
| Pain Scores | Visual analog scale (VAS) pain score on a scale of 1-10 (increments of 1 unit), 1 being no pain at all and 10 being the most pain the patient has ever experienced | 24 hour after arrival time in post anesthesia care unit |
| Opioid side effect - Nausea | Incident of opioid side effect - Nausea | After arrival time to post anesthesia care unit until 24 hrs./completion of study |
| Opioid side effect - Puritis | Incident of opioid side effect - Puritis | After arrival time to post anesthesia care unit until 24 hrs./completion of study |
| Opioid side effect - Respiratory Depression | Incident of opioid side effect - Respiratory Depression | After arrival time to post anesthesia care unit until 24 hrs./completion of study |
| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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