Peri-Operative Steroid Management in Patients (Steroid)
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ClinicalTrials.gov Identifier: NCT02084134 |
Recruitment Status
:
Completed
First Posted
: March 11, 2014
Results First Posted
: March 1, 2018
Last Update Posted
: April 11, 2018
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During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by making a small hole in the back of the nose into the bottom of the skull. The surgeon is able to see the pituitary and tumor with an endoscope and remove the tumor through the hole.
Surgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure, and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons about the use of perioperative steroids in pituitary patients. Traditionally, all patients undergoing pituitary surgery were given steroids before, during, and after surgery because of the assumption that there would be some compromise in the amount of ACTH released by the pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result, there are some centers that routinely give perioperative steroids to all patients undergoing pituitary surgery and there are some centers that do not routinely give perioperative steroids. There are several retrospective and prospective studies that have addressed this issue and have shown that withholding perioperative steroids is safe, but there has never been a prospective study comparing the two approaches.
Objectives: The goal of this study is to prospectively compare two approaches to the perioperative management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst. One protocol includes the routine use of perioperative steroids and the other does not. The investigators hypothesis, based on previous studies, is that patients who are adrenally sufficient do not routinely need to be treated with perioperative steroids. The investigators also hypothesize that the use of perioperative steroids may be associated with a higher rate of adverse outcomes
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pituitary Adenoma Pituitary Diseases | Drug: hydrocortisone Drug: dexamethasone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | November 21, 2016 |
Actual Study Completion Date : | December 31, 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: steroid treatment arm
Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg
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Drug: hydrocortisone
100mg at the time of surgery
Other Name: intravenous hydrocortisone
Drug: dexamethasone
0.5mg every 6 hours for a total of four doses
Other Name: intravenous dexamethasone
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No Intervention: non-steroid treatment
Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
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- Number of Participants With Adrenal Insufficiency [ Time Frame: 6 weeks following surgery ]Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test
- Percentage of Patients Discharged on Glucocorticoids [ Time Frame: 1 day (Day of hospital discharge) ]Patient charts were reviewed to identify patients who were discharged on prednisone

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin secreting, growth hormone secreting, gonadotropin secreting, or TSH (Thyrotropin secreting hormone) scheduled to undergo transsphenoidal resection.
Exclusion Criteria:
- Patients with Cushing's Disease (pituitary tumor which secretes ACTH)
- Patients with a history of pituitary apoplexy (condition caused by hemorrhage into a pituitary adenoma which causes headache, double vision and hypopituitarism)
- Patients on long term glucocorticoid therapy
- Patients with adrenal insufficiency or who have not had their adrenal response evaluated prior to surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084134
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Julie M. Silverstein, M.D. | Washington University School of Medicine |
Additional Information:
Publications:
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT02084134 History of Changes |
Other Study ID Numbers: |
201110174 |
First Posted: | March 11, 2014 Key Record Dates |
Results First Posted: | March 1, 2018 |
Last Update Posted: | April 11, 2018 |
Last Verified: | March 2018 |
Keywords provided by Washington University School of Medicine:
pituitary adenoma Pituitary Tumor transsphenoidal resection pituitary cyst |
Additional relevant MeSH terms:
Pituitary Diseases Pituitary Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Adenoma Hypothalamic Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Dexamethasone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate Dexamethasone Hydrocortisone BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |