Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery

Pontificia Universidad Catolica de Chile

Status and phase: Unknown; Phase 4

Conditions: Pituitary Neoplasms

Treatments: Drug: Dexmedetomidine; Drug: Sodium Chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT02549768

15-095

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sodium Chloride 0.9%