CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
hydrocortisone +1 moredrug
Likely dose
hydrocortisone 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02084134
NCT02084134N/ACompleted

The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts

Washington University School of Medicine·interventional·Posted Mar 11, 2014·Updated Apr 11, 2018

In Brief

A clinical study evaluating hydrocortisone and dexamethasone for Pituitary Adenoma and Pituitary Diseases. Completed, enrolled 43 participants across 1 site.

Detailed 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 perioperative steroids may be associated with a higher rate of adverse outcomes

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2014
Enrollment StartMar 1, 2012
Primary CompletionNov 21, 2016
Study CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 12.3 years ago

Interventions

hydrocortisonedrug

100mg at the time of surgery

dexamethasonedrug

0.5mg every 6 hours for a total of four doses