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

Non-functioning Pituitary Adenoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05005715
• Other study ID #: TSA_precedex
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 30, 2021
• Est. completion date: August 29, 2023

Study information

• Verified date: August 2021
• Source: Seoul National University Hospital
• Contact: Hee-pyoung Park, MD, PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Non-functioning Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Drug:
• Dexmedetomidine
Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.
• normal 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Time to the first administration of rescue analgesics after the end of surgery		postoperative (up to 2 weeks after surgery)
Secondary	Total amounts of rescue analgesics		postoperative (up to 2 weeks after surgery)
Secondary	Total amounts of propofol and remifentanil administered during surgery		intraoperative (from induction of anesthesia until end of anesthesia)
Secondary	Time to emergence after the end of surgery		postoperative (up to 1 day after surgery)
Secondary	Time to extubation after the end of surgery		postoperative (up to 1 day after surgery)
Secondary	Incidence and severity of postoperative complications	nausea, vomiting, etc.	postoperative (up to 2 weeks after surgery)
Secondary	Hospital length of stay		postoperative (up to 2 weeks after surgery)