Clinical trial NCT02549768: Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery
Official title: Effect of Dexmedetomidine as Anesthetic Coadjuvant on Plasmatic Cortisol Response in Transsphenoidal Surgery for Pituitary Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pituitary Neoplasms
Keywords: Dexmedetomidine
Pituitary
Transsphenoidal
Cortisol
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cortisol plasmatic levels
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Adrenocorticotropin hormone
timeFrame: One hour after surgery, 24 hours after surgery, 48 hours after surgery
measure: Hemodynamics
timeFrame: From start of anesthesia to end of anesthesia
measure: Nausea and vomiting
timeFrame: 24 hours after surgery
measure: Pain
timeFrame: 24 hours after surgery
measure: Patient comfort
timeFrame: 24 hours after discharge from hospital
measure: Diabetes insipidus incidence
timeFrame: 24 hours after surgery and 3 months after surgery
measure: Cerebrospinal fluid fistula
timeFrame: 3 months after surgery
measure: Cortisol plasmatic levels
timeFrame: 1 hour after surgery, 48 hours after surgery, 3 months after surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Division de Anestesia - Pontificia Universidad Catolica de Chile
state: Region Metropolitana
Study officials:
affiliation: Physician
name: Juan C Pedemonte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assisstant adjunct professor
name: Pablo Villanueva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrasco CA, Villanueva G P. [Selective use of glucocorticoids during the perioperative period of transsphenoidal surgery for pituitary tumors]. Rev Med Chil. 2014 Sep;142(9):1113-9. doi: 10.4067/S0034-98872014000900004. Spanish.
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citation: Gopalakrishna KN, Dash PK, Chatterjee N, Easwer HV, Ganesamoorthi A. Dexmedetomidine as an Anesthetic Adjuvant in Patients Undergoing Transsphenoidal Resection of Pituitary Tumor. J Neurosurg Anesthesiol. 2015 Jul;27(3):209-15. doi: 10.1097/ANA.0000000000000144.
citation: Raekallio MR, Kuusela EK, Lehtinen ME, Tykkylainen MK, Huttunen P, Westerholm FC. Effects of exercise-induced stress and dexamethasone on plasma hormone and glucose concentrations and sedation in dogs treated with dexmedetomidine. Am J Vet Res. 2005 Feb;66(2):260-5. doi: 10.2460/ajvr.2005.66.260.
citation: Mukhtar AM, Obayah EM, Hassona AM. The use of dexmedetomidine in pediatric cardiac surgery. Anesth Analg. 2006 Jul;103(1):52-6, table of contents. doi: 10.1213/01.ane.0000217204.92904.76.
citation: Nomikos P, Ladar C, Fahlbusch R, Buchfelder M. Impact of primary surgery on pituitary function in patients with non-functioning pituitary adenomas -- a study on 721 patients. Acta Neurochir (Wien). 2004 Jan;146(1):27-35. doi: 10.1007/s00701-003-0174-3. Epub 2004 Jan 7.
citation: Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.