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Completed

NCT Number: NCT05005715

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

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.

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Key information

Conditions

Non-functioning Pituitary Adenoma

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Drug

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

Primary outcomes

  1. Quality of recovery-15 (QoR-15) score

    Time frame: 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 outcomes

  1. Serum level of triiodothyronine (T3)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    ng/dL

  2. Serum level of triiodothyronine (T4)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    ng/dL

  3. Serum level of thyroid stimulating hormone (TSH)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    uIU/mL

  4. Serum level of luteinizing hormone (LH)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    mIU/mL

  5. Serum level of follicle stimulating hormone (FSH)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    mIU/mL

  6. Serum level of adredocorticotrophic hormone (ACTH)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    pg/mL

  7. Serum level of growth hormone (GH)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    ng/mL

  8. Serum level of insulin-like growth factor-1 (IGF-1)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    ng/mL

  9. Serum level of prolactin

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    ng/mL

  10. Serum level of antidiuretic hormone (ADH)

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    pg/ml

  11. Serum level of cortisol

    Time frame: preoperative (1-2 month before surgery), intraoperative (when surgeon starts tumor resection), immediately postoperative (30 min after the end of surgery)

    ug/dL

  12. Pain score (visual analogue scale, VAS)

    Time frame: 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).

  13. Time to the first administration of rescue analgesics after the end of surgery

    Time frame: postoperative (up to 2 weeks after surgery)

  14. Total amounts of rescue analgesics

    Time frame: postoperative (up to 2 weeks after surgery)

  15. Total amounts of propofol and remifentanil administered during surgery

    Time frame: intraoperative (from induction of anesthesia until end of anesthesia)

  16. Time to emergence after the end of surgery

    Time frame: postoperative (up to 1 day after surgery)

  17. Time to extubation after the end of surgery

    Time frame: postoperative (up to 1 day after surgery)

  18. Incidence and severity of postoperative complications

    Time frame: postoperative (up to 2 weeks after surgery)

    nausea, vomiting, etc.

  19. Hospital length of stay

    Time frame: postoperative (up to 2 weeks after surgery)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 13, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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