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In multiple previous studies that have explored the use of dexmedetomidine in transsphenoidal tumor resection surgery, dexmedetomidine showed many beneficial effects like reducing the requirement of analgesics and anesthetics, improving hemodynamic stability and decreasing the emergence time, extubation time and visual analog scale at emergence. Therefore, the investigators hypothesized that dexmedetomidine would decrease neuroendocrine stress response and improve the quality of postoperative recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Active Comparator | After the induction of anesthesia, the dexmedetomidine group received intravenous dexmedetomidine at a loading dose of 1µg/kg for 10 min, followed by a maintenance dose of 0.5µg/kg/h until the end of surgery. |
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| Control group | Placebo Comparator | After the induction of anesthesia, the control group received intravenous normal saline at the same loading volume for 10 min, followed by the same volume until the end of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery-15 (QoR-15) score | Self-rated questionnaire composed of 15 items (each item: 0-10 points, total: 0-150 points) of five dimensions: physical well-being, physical independence, emotional state, psychological support, and pain. Higher scores indicate better quality of recovery. | postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of triiodothyronine (T3) | ng/dL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of triiodothyronine (T4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee-pyoung Park, MD, PhD | Contact | 82-2-2072-2466 | hppark@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| normal saline | Drug | Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery. |
|
ng/dL
| preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of thyroid stimulating hormone (TSH) | uIU/mL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of luteinizing hormone (LH) | mIU/mL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of follicle stimulating hormone (FSH) | mIU/mL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of adredocorticotrophic hormone (ACTH) | pg/mL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of growth hormone (GH) | ng/mL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of insulin-like growth factor-1 (IGF-1) | ng/mL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of prolactin | ng/mL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of antidiuretic hormone (ADH) | pg/ml | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Serum level of cortisol | ug/dL | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) |
| Pain score (visual analogue scale, VAS) | Self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). | postoperative 4 hour, 1 day, 2 day |
| Time to the first administration of rescue analgesics after the end of surgery | postoperative (up to 2 weeks after surgery) |
| Total amounts of rescue analgesics | postoperative (up to 2 weeks after surgery) |
| Total amounts of propofol and remifentanil administered during surgery | intraoperative (from induction of anesthesia until end of anesthesia) |
| Time to emergence after the end of surgery | postoperative (up to 1 day after surgery) |
| Time to extubation after the end of surgery | postoperative (up to 1 day after surgery) |
| Incidence and severity of postoperative complications | nausea, vomiting, etc. | postoperative (up to 2 weeks after surgery) |
| Hospital length of stay | postoperative (up to 2 weeks after surgery) |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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