跳至主要内容
临床试验/NCT02549768
NCT02549768Unknown4 期

Effect of Dexmedetomidine as Anesthetic Coadjuvant on Plasmatic Cortisol Response in Transsphenoidal Surgery for Pituitary Tumors

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
40
试验地点
1
主要终点
Cortisol plasmatic levels

研究概览

简要总结

Use of dexmedetomidine in pituitary tumor resection surgery as adjuvant drug and its relation to cortisol levels during postoperative period.

详细描述

Transsphenoidal resection of pituitary tumors is the neurosurgical procedure of choice to remove most of the tumors of the sellar region. Sometimes the intervention produces dysfunction of the hypothalamic-pituitary axis, and although most are transient, the risk associated with post-operative hypocortisolism determines its evaluation early in the postoperative period and the possibility of steroidal supplementation posteriorly. It is described that dexmedetomidine can be used as an adjuvant drug in this type of surgery being useful in reduction of total consumption of opioids and anesthetic gases, maintain hemodynamic stability and less time to recovery from anesthesia. Due to its sympatholytic effect, dexmedetomidine has been found to alter the intraoperative common neuroendocrine response generating lower levels of cortisol in the postoperative period than patients in which is not used.

The main objective of this study is to evaluate corticosteroid axis response (cortisol and adrenocorticotropic hormone) in patients undergoing transsphenoidal surgery under anesthesia with dexmedetomidine. A single-center randomized double-blind clinical trial will be conducted that will compare two groups of patients, one of which will be given dexmedetomidine (Dex group) and another group who will receive a placebo (control group). In addition the incidence of perioperative complications (nausea, vomiting, diabetes insipidus), intraoperative hemodynamics and patient comfort. The investigators expect that the normal stress response to surgery measured by cortisol and adrenocorticotropic hormone in the postoperative period will be reduced in the dexmedetomidine arm. This effect should be transient and attributed to use of dexmedetomidine and not to surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status I or II.
  • Pituitary tumour: non-functional macroadenoma, Rathke's cleft cyst, acromegaly.
  • Normal hypothalamic-pituitary-adrenal axis by hormone levels measurement previous to surgery.

排除标准

  • Cushing disease.
  • Pituitary apoplexy.
  • Craniopharyngioma.
  • Chronic corticosteroid use.
  • Hemodynamic instability.
  • Altered consciousness (Glasgow Coma Scale score less than 15).
  • Atrioventricular block in any degree.
  • Preoperative bradycardia.
  • Alpha 2 agonist use (clonidine, alpha-methyldopa)
  • Pregnancy or breast feeding.
  • Known allergy to any of the study drugs.

研究组 & 干预措施

Dexmedetomidine

Active Comparator

Use of dexmedetomidine during surgery (1 mcg/kg in 10 minutes, then infusion at 0.7 mcg/kg/h)

干预措施: Dexmedetomidine (Drug)

Placebo

Placebo Comparator

Use of crystalloid solution (sodium chloride 0.9%), injection pump programmed with drug "Dexmedetomidine" with 1 mcg/kg in 10 minutes, infusion 0.7 mcg/kg/h.

干预措施: Sodium Chloride 0.9% (Drug)

结局指标

主要结局

Cortisol plasmatic levels

时间窗: 24 hours after surgery

Venous blood sample

次要结局

  • Nausea and vomiting(24 hours after surgery)
  • Pain(24 hours after surgery)
  • Patient comfort(24 hours after discharge from hospital)
  • Diabetes insipidus incidence(24 hours after surgery and 3 months after surgery)
  • Adrenocorticotropin hormone(One hour after surgery, 24 hours after surgery, 48 hours after surgery)
  • Hemodynamics(From start of anesthesia to end of anesthesia)
  • Cerebrospinal fluid fistula(3 months after surgery)
  • Cortisol plasmatic levels(1 hour after surgery, 48 hours after surgery, 3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验