Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to respond quickly either during intraoperative testing or at the conclusion of surgery.
As part of this study, anesthesiologists will be given additional data on the expected drug effects based on a computer simulation. The data will be provided as a suggestion and will be used together with all the other information normally used to keep the study subjects safely asleep during surgery. In addition, data will be collected from the medical history and on postoperative pain control and medication side effects for the first 24 hours. Specifically, study subjects will be asked to rate their pain on a 10-point scale after they wake up from surgery and once they arrive in the pediatric intensive care unit. Measures of the time from the end of surgery until the study subjects are awake and out of the operating room will also be collected.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anesthesia optimization | Experimental | Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacokinetic simulation | Other | The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 4-Item Pain Intensity Measure | 0 - 10 (0=no pain; 10 = pain as bad as can be) | 24 hours |
| Respiratory depression | Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Utility of pharmacokinetic simulation | The number of modifications to the anesthetic dosing | 4 - 8 hours (Intraoperative period) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christoph Seubert, MD PhD DABNM | 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 |
|---|---|---|---|
| 32905725 | Derived | Tams C, Dooley FC, Sangari TS, Gonzalez-Rodriguez SN, Stoker RE, Phillips SA, Koenig M, Wishin JM, Molinari SC, Blakemore LC, Seubert CN. Methadone and a Clinical Pathway in Adolescent Idiopathic Scoliosis Surgery: A Historically Controlled Study. Global Spine J. 2020 Oct;10(7):837-843. doi: 10.1177/2192568219878135. Epub 2019 Sep 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |