Clinical trial NCT05005715: Effect of Dexmedetomidine on Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Surgery
Official title: Effect of Dexmedetomidine on Intraoperative Neuroendocrine Stress Response and Early Postoperative Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Tumor Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-functioning Pituitary Adenoma
Keywords: non-functioning Pituitary Adenoma
endoscopic transsphenoidal tumor surgery
dexmedetomidine
quality of recovery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of recovery-15 (QoR-15) score
timeFrame: postoperative day 1
Secondary outcomes:
measure: Serum level of triiodothyronine (T3)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of triiodothyronine (T4)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of thyroid stimulating hormone (TSH)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of luteinizing hormone (LH)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of follicle stimulating hormone (FSH)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of adredocorticotrophic hormone (ACTH)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of growth hormone (GH)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of insulin-like growth factor-1 (IGF-1)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of prolactin
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of antidiuretic hormone (ADH)
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Serum level of cortisol
timeFrame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)
measure: Pain score (visual analogue scale, VAS)
timeFrame: postoperative 4 hour, 1 day, 2 day
measure: Time to the first administration of rescue analgesics after the end of surgery
timeFrame: postoperative (up to 2 weeks after surgery)
measure: Total amounts of rescue analgesics
timeFrame: postoperative (up to 2 weeks after surgery)
measure: Total amounts of propofol and remifentanil administered during surgery
timeFrame: intraoperative (from induction of anesthesia until end of anesthesia)
measure: Time to emergence after the end of surgery
timeFrame: postoperative (up to 1 day after surgery)
measure: Time to extubation after the end of surgery
timeFrame: postoperative (up to 1 day after surgery)
measure: Incidence and severity of postoperative complications
timeFrame: postoperative (up to 2 weeks after surgery)
measure: Hospital length of stay
timeFrame: postoperative (up to 2 weeks after surgery)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: