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Peri-Operative Steroid Management in Patients

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Washington University School of Medicine

关键词

抽象

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

描述

Patients who are scheduled to undergo transsphenoidal resection for a pituitary tumor or cyst at the investigators institution will be screened prior to surgery for eligibility for this study. All patients deemed eligible will undergo a cosyntropin stimulation test to evaluate for adrenal insufficiency. Patients with adrenal insufficiency will be excluded from the study.

日期

最后验证: 02/28/2018
首次提交: 03/04/2014
提交的预估入学人数: 03/09/2014
首次发布: 03/10/2014
上次提交的更新: 03/14/2018
最近更新发布: 04/10/2018
首次提交结果的日期: 01/30/2018
首次提交质量检查结果的日期: 01/30/2018
首次发布结果的日期: 02/28/2018
实际学习开始日期: 02/29/2012
预计主要完成日期: 11/20/2016
预计完成日期: 12/30/2016

状况或疾病

Pituitary Adenoma
Pituitary Diseases

干预/治疗

Drug: steroid treatment arm

Drug: steroid treatment arm

-

手臂组

干预/治疗
Active Comparator: steroid treatment arm
Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg
Drug: steroid treatment arm
100mg at the time of surgery
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).

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

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

结果

主要结果指标

1. Number of Participants With Adrenal Insufficiency [6 weeks following surgery]

Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test

次要成果指标

1. Percentage of Patients Discharged on Glucocorticoids [1 day (Day of hospital discharge)]

Patient charts were reviewed to identify patients who were discharged on prednisone

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