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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
At start of anesthesia, bolus of 1 mcg/kg of dexmedetomidine over 10 minutes and then infusion of 0.7 mcg/kg/h during surgery will be administered.
Sodium chloride 0.9% with a pump programmed in same way as Dexmedetomidine pump
Division de Anestesia - Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
RECRUITINGCortisol plasmatic levels
Venous blood sample
Time frame: 24 hours after surgery
Adrenocorticotropin hormone
Venous blood sample
Time frame: One hour after surgery, 24 hours after surgery, 48 hours after surgery
Hemodynamics
Heart rate and arterial pressure
Time frame: From start of anesthesia to end of anesthesia
Nausea and vomiting
Semiquantitative measure
Time frame: 24 hours after surgery
Pain
By visual analogue scale
Time frame: 24 hours after surgery
Patient comfort
Scale ranging from 1 (very unsatisfied) to 5 (very satisfied)
Time frame: 24 hours after discharge from hospital
Diabetes insipidus incidence
Clinical diagnosis by urine output (polyuria over 3 liters or urine per day) and/or hypernatremia (plasmatic sodium over 145 meq/L)
Time frame: 24 hours after surgery and 3 months after surgery
Cerebrospinal fluid fistula
Clinical diagnosis made by neurosurgeon
Time frame: 3 months after surgery
Cortisol plasmatic levels
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Venous blood sample
Time frame: 1 hour after surgery, 48 hours after surgery, 3 months after surgery