Perioperative steroid administration versus no steroid administration in patients with intact hypothalamic-pituitary axis undergoing Endoscopic transsphenoidal resection of pituitary adenoma: A randomized control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1. To compare the perioperative serum cortisol levels and
研究概览
简要总结
HypothesisPatients undergoing pituitary adenoma surgery are given perioperative Stress dose Hydrocortisone replacement therapy. This perioperative replacement can be safely avoided given the myriad of side effects of steroids in patients with intact HPA axis function
Research questionsWill the incidence of new-onset Adrenal insufficiency in the postoperative period be affected by the withholding of perioperative hydrocortisone replacement therapy as compared to those receiving hydrocortisone replacement therapy
Aims and Objectives
AimTo assess if perioperative hydrocortisone supplementation can be avoided in patients with an intact hypothalamus pituitary adrenal (HPA) axis for pituitary adenoma via endoscopic trans nasal resection
Objective:
1 To compare the perioperative serum cortisol levels.
2 The incidence of adrenal insufficiency postoperatively after endoscopic trans nasal resection in patients of pituitary adenoma with an intact hypothalamic pituitary adrenal or HPA axis during the 1st three postoperative days for the primary outcome and the 1st 3 months postoperatively for secondary outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Pituitary adenoma requiring endoscopic transsphenoidal surgical resection 2 Intact HPA axis.
排除标准
- •1 Patients with preoperative adrenal insufficiency or Cushings Disease 2 Patients on steroids for other systemic illnesses 3 Patients on drugs that could affect the HPA axis 4 Patients refusing consent for surgery/study.
- •5 Pregnancy.
结局指标
主要结局
1. To compare the perioperative serum cortisol levels and
时间窗: Preoperative period | Post operative day 1 | Post operative day 2
2. The incidence of adrenal insufficiency postoperatively after endoscopic trans nasal resection in patients of pituitary adenoma with an intact hypothalamic-pituitary-adrenal (HPA) axis during the 1st three postoperative days for the primary outcome
时间窗: Preoperative period | Post operative day 1 | Post operative day 2
次要结局
- The incidence of adrenal insufficiency postoperatively(after endoscopic transnasal resection in patients of pituitary adenoma with an)
研究者
Karthik J S
AIIMS Jodhpur