Effect of Dexmedetomidine on Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-functioning Pituitary Adenoma

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine group<br>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. | Drug: Dexmedetomidine<br>* Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.<br>|
| Placebo Comparator: Control group<br>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. | Drug: normal saline<br>* Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-functioning Pituitary Adenoma, endoscopic transsphenoidal tumor surgery, dexmedetomidine, quality of recovery