Pituitary Neoplasms
Conditions
Keywords
Dexmedetomidine, Pituitary, Transsphenoidal, Cortisol
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.
Interventions
DRUGDexmedetomidine
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.
DRUGSodium Chloride 0.9%
Sodium chloride 0.9% with a pump programmed in same way as Dexmedetomidine pump
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol plasmatic levels | 24 hours after surgery | Venous blood sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamics | From start of anesthesia to end of anesthesia | Heart rate and arterial pressure |
| Nausea and vomiting | 24 hours after surgery | Semiquantitative measure |
| Pain | 24 hours after surgery | By visual analogue scale |
| Adrenocorticotropin hormone | One hour after surgery, 24 hours after surgery, 48 hours after surgery | Venous blood sample |
| Diabetes insipidus incidence | 24 hours after surgery and 3 months after surgery | Clinical diagnosis by urine output (polyuria over 3 liters or urine per day) and/or hypernatremia (plasmatic sodium over 145 meq/L) |
| Cerebrospinal fluid fistula | 3 months after surgery | Clinical diagnosis made by neurosurgeon |
| Cortisol plasmatic levels | 1 hour after surgery, 48 hours after surgery, 3 months after surgery | Venous blood sample |
| Patient comfort | 24 hours after discharge from hospital | Scale ranging from 1 (very unsatisfied) to 5 (very satisfied) |
Countries
Chile
Contacts
Primary ContactJuan C Pedemonte, MD
Backup ContactPablo Villanueva, MD
Outcome results
None listed