Effect of Dexmedetomidine on Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Surgery
- Conditions
- Non-functioning Pituitary Adenoma
- Interventions
- Drug: normal saline
- Registration Number
- NCT05005715
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
- Non-functioning patients undergoing endoscopic transsphenoidal tumor surgery under general anesthesia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group normal saline 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. Dexmedetomidine group Dexmedetomidine 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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).
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
Incidence and severity of postoperative complications postoperative (up to 2 weeks after surgery) nausea, vomiting, etc.
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
Time to the first administration of rescue analgesics after the end of surgery 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) 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
Time to emergence after the end of surgery postoperative (up to 1 day after surgery) Hospital length of stay postoperative (up to 2 weeks after surgery) 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 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
Total amounts of rescue analgesics postoperative (up to 2 weeks after surgery) Time to extubation after the end of surgery postoperative (up to 1 day after surgery)
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of