Non-functioning Pituitary AdenomaPhase 2NCT05005715
Effect of Dexmedetomidine on Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Surgery
A Phase 2 study testing Dexmedetomidine and normal saline in people with Non-functioning Pituitary Adenoma, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Non-functioning Pituitary Adenoma
- What is being tested?
- Dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2021to 4 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-functioning patients undergoing endoscopic transsphenoidal tumor surgery under general anesthesia
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Non-functioning Pituitary Adenoma
- Being tested
- Dexmedetomidine, normal saline
- Keywords
- non-functioning Pituitary Adenoma, endoscopic transsphenoidal tumor surgery, dexmedetomidine, quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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 salineDrug
Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | 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. Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | 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. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative day 1
Secondary outcomes (19)
Serum level of triiodothyronine (T3)
ng/dL
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: postoperative 4 hour, 1 day, 2 day
Time to the first administration of rescue analgesics after the end of surgery
Measured: postoperative (up to 2 weeks after surgery)
Total amounts of rescue analgesics
Measured: postoperative (up to 2 weeks after surgery)
Total amounts of propofol and remifentanil administered during surgery
Measured: intraoperative (from induction of anesthesia until end of anesthesia)
Time to emergence after the end of surgery
Measured: postoperative (up to 1 day after surgery)
Time to extubation after the end of surgery
Measured: postoperative (up to 1 day after surgery)
Incidence and severity of postoperative complications
nausea, vomiting, etc.
Measured: postoperative (up to 2 weeks after surgery)
Hospital length of stay
Measured: postoperative (up to 2 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start31 Aug 2021
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-functioning Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005715
- Sponsor's protocol ID
- TSA_precedex
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2021
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05005715
- Acronym / sponsor ID
- TSA_precedex
- Conditions
- Non-functioning Pituitary Adenoma
- Keywords
- non-functioning Pituitary Adenoma, endoscopic transsphenoidal tumor surgery, dexmedetomidine, quality of recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: DexmedetomidineAfter 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. |
| Control group | Placebo comparator | Drug: normal salineAfter 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-functioning patients undergoing endoscopic transsphenoidal tumor surgery under general anesthesia
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery. | Drug | Dexmedetomidine group |
| normal salinePatients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery. | Drug | Control group |
Primary outcome
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.
19 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Pain score (visual analogue scale, VAS)
Time frame: postoperative 4 hour, 1 day, 2 day
Time to the first administration of rescue analgesics after the end of surgery
Time frame: postoperative (up to 2 weeks after surgery)
Total amounts of rescue analgesics
Time frame: postoperative (up to 2 weeks after surgery)
Total amounts of propofol and remifentanil administered during surgery
Time frame: intraoperative (from induction of anesthesia until end of anesthesia)
Time to emergence after the end of surgery
Time frame: postoperative (up to 1 day after surgery)
Time to extubation after the end of surgery
Time frame: postoperative (up to 1 day after surgery)
Incidence and severity of postoperative complications
Time frame: postoperative (up to 2 weeks after surgery)
Hospital length of stay
Time frame: postoperative (up to 2 weeks after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine and normal saline in people with Non-functioning Pituitary Adenoma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery-15 (QoR-15) score (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.