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NCT02084134 · ClinicalTrials.gov registry record · NA
Peri-Operative Steroid Management in Patients
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT02084134 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 43 participants.
The verdict
NCT02084134, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
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 pe
Interventions
- DRUG dexamethasone
- DRUG hydrocortisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02084134
The ClinicalTrials.gov registry entry for NCT02084134 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which dexamethasone is the first listed.
NCT02084134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02084134 about?
NCT02084134 is a clinical study titled "Peri-Operative Steroid Management in Patients". 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 tum...
What is the current status of trial NCT02084134?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2012-03. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT02084134?
The interventions under investigation include: dexamethasone (DRUG), hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT02084134?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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