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Comparison of intraoperative cortisol level after preoperative hydrocortisone administration versus placebo in patients with normal hypothalamic-pituitary-adrenal axis undergoing transsphenoidal removal of nonfunctioning pituitary adenoma

Comparison of intraoperative cortisol level after preoperative hydrocortisone administration versus placebo in patients with normal hypothalamic-pituitary-adrenal axis undergoing transsphenoidal removal of nonfunctioning pituitary adenoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002426
Enrollment
42
Registered
2017-08-25
Start date
2017-09-01
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Group N: Normal saline 10 mL intravenous injection Group S: hydrocortisone 100 mg + normal saline 10 mL intravenous injection Hydrocortisone 100 mg is a commonly used concentration for stress d

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients with nonfunctional pituitary adenomas scheduled for TSA surgery at 8 am at the Seoul National University Hospital, whose morning cortisol levels were normal (over 5 ug / dL) or insulin tolerance test or rapid ACTH test (peak> 18ug / DL).

Exclusion criteria

Exclusion criteria: ? functional pituitary tumor ? pituitary apoplexy ? steroid users within the last 3 months ? steroid treatment for other reasons during surgery (cerebral edema, visual loss, airway edema, nausea / vomiting, minimal residual gland visualized) ? taking drugs affecting the HPA axis (oral pill, etomidate, ketoconazole, metyrapone, mitotane, tyrosine kinase inhibitors, megestrol, anticoagulants) ? previous brain or adrenal gland operation history

Design outcomes

Primary

MeasureTime frame
serum cortisol level

Secondary

MeasureTime frame
serum ACTH level;serum glucose level;cardiovarcular collapse (SBP < 80mmHg or HR > 120 or HR < 40) incidence, duration;steroid treatment and cause;steroid dependency

Countries

Korea, Republic of

Contacts

Public ContactHyung-Chul Lee

Seoul National University Hospital

lucid80@gmail.com+82-2-2072-2469

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 18, 2026