Non-functioning Pituitary Adenoma
Conditions
Keywords
non-functioning Pituitary Adenoma, endoscopic transsphenoidal tumor surgery, dexmedetomidine, quality of recovery
Brief summary
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.
Interventions
DRUGDexmedetomidine
Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.
DRUGnormal saline
Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Non-functioning patients undergoing endoscopic transsphenoidal tumor surgery under general anesthesia
Exclusion criteria
* Patients who do not agree to participate in the study * Patients with contraindication to dexmedetomidine * Patients with previous history of endoscopic transsphenoidal tumor surgery * Patients who take anticoagulants or have bleeding disorder * Patients with conduction block or cardiovascular disease * Patients with psychiatric disease such as dementia, delirium * Patients have difficulty filling out the QoR-15 questionnaire * Pregnant or lactating women * Patients who have allergies to propofol, remifentanil, fentanyl or rocuronium * Patients with myasthenia gravis or myasthenic syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery-15 (QoR-15) score | postoperative day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum level of triiodothyronine (T3) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | ng/dL |
| Serum level of triiodothyronine (T4) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | ng/dL |
| Serum level of thyroid stimulating hormone (TSH) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | uIU/mL |
| Serum level of luteinizing hormone (LH) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | mIU/mL |
| Serum level of follicle stimulating hormone (FSH) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | mIU/mL |
| Serum level of adredocorticotrophic hormone (ACTH) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | pg/mL |
| Serum level of growth hormone (GH) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | ng/mL |
| Serum level of insulin-like growth factor-1 (IGF-1) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | ng/mL |
| Serum level of prolactin | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | ng/mL |
| Serum level of antidiuretic hormone (ADH) | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | pg/ml |
| Serum level of cortisol | preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery) | ug/dL |
| Pain score (visual analogue scale, VAS) | postoperative 4 hour, 1 day, 2 day | 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). |
| 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 | postoperative (up to 2 weeks after surgery) | nausea, vomiting, etc. |
| Hospital length of stay | postoperative (up to 2 weeks after surgery) | — |
Countries
South Korea
Outcome results
None listed