Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery

Pituitary Neoplasms Clinical Trial

Official title:

Effect of Dexmedetomidine as Anesthetic Coadjuvant on Plasmatic Cortisol Response in Transsphenoidal Surgery for Pituitary Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02549768
• Other study ID #: 15-095
• Status: Recruiting
• Phase: Phase 4
• First received: September 6, 2015
• Last updated: October 10, 2016
• Start date: September 2015
• Est. completion date: August 2017

Study information

• Verified date: October 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: Juan C Pedemonte, MD
• Phone: 56-2-23543270
• Email: jcpedemo[@]gmail.com
• Is FDA regulated: No
• Health authority: Chile: Comité de Bioética
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Drug:
• Dexmedetomidine
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%
Sodium chloride 0.9% with a pump programmed in same way as Dexmedetomidine pump

Locations

Country	Name	City	State
Chile	Division de Anestesia - Pontificia Universidad Catolica de Chile	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (9)

Ali Z, Prabhakar H, Bithal PK, Dash HH. Bispectral index-guided administration of anesthesia for transsphenoidal resection of pituitary tumors: a comparison of 3 anesthetic techniques. J Neurosurg Anesthesiol. 2009 Jan;21(1):10-5. doi: 10.1097/ANA.0b013e3181855732. — View 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. — View Citation

Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. — View 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. — View 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. — View Citation

Hout WM, Arafah BM, Salazar R, Selman W. Evaluation of the hypothalamic-pituitary-adrenal axis immediately after pituitary adenomectomy: is perioperative steroid therapy necessary? J Clin Endocrinol Metab. 1988 Jun;66(6):1208-12. — View 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. — View 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. Epub 2004 Jan 7. Erratum in: Acta Neurochir (Wien). 2004 Apr;146(6):433. — View Citation

Raekallio MR, Kuusela EK, Lehtinen ME, Tykkyläinen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol plasmatic levels	Venous blood sample	24 hours after surgery	No
Secondary	Adrenocorticotropin hormone	Venous blood sample	One hour after surgery, 24 hours after surgery, 48 hours after surgery	No
Secondary	Hemodynamics	Heart rate and arterial pressure	From start of anesthesia to end of anesthesia	Yes
Secondary	Nausea and vomiting	Semiquantitative measure	24 hours after surgery	Yes
Secondary	Pain	By visual analogue scale	24 hours after surgery	Yes
Secondary	Patient comfort	Scale ranging from 1 (very unsatisfied) to 5 (very satisfied)	24 hours after discharge from hospital	Yes
Secondary	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)	24 hours after surgery and 3 months after surgery	Yes
Secondary	Cerebrospinal fluid fistula	Clinical diagnosis made by neurosurgeon	3 months after surgery	Yes
Secondary	Cortisol plasmatic levels	Venous blood sample	1 hour after surgery, 48 hours after surgery, 3 months after surgery	No