Pituitary Neoplasms Clinical Trial
Official title:
Effect of Dexmedetomidine as Anesthetic Coadjuvant on Plasmatic Cortisol Response in Transsphenoidal Surgery for Pituitary Tumors
Use of dexmedetomidine in pituitary tumor resection surgery as adjuvant drug and its relation to cortisol levels during postoperative period.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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