Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery
Primary Purpose
Pituitary Neoplasms
Status
Unknown status
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Dexmedetomidine
Sodium Chloride 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Neoplasms focused on measuring Dexmedetomidine, Pituitary, Transsphenoidal, Cortisol
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.
Sites / Locations
- Division de Anestesia - Pontificia Universidad Catolica de ChileRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexmedetomidine
Placebo
Arm Description
Use of dexmedetomidine during surgery (1 mcg/kg in 10 minutes, then infusion at 0.7 mcg/kg/h)
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.
Outcomes
Primary Outcome Measures
Cortisol plasmatic levels
Venous blood sample
Secondary Outcome Measures
Adrenocorticotropin hormone
Venous blood sample
Hemodynamics
Heart rate and arterial pressure
Nausea and vomiting
Semiquantitative measure
Pain
By visual analogue scale
Patient comfort
Scale ranging from 1 (very unsatisfied) to 5 (very satisfied)
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)
Cerebrospinal fluid fistula
Clinical diagnosis made by neurosurgeon
Cortisol plasmatic levels
Venous blood sample
Full Information
NCT ID
NCT02549768
First Posted
September 6, 2015
Last Updated
October 10, 2016
Sponsor
Pontificia Universidad Catolica de Chile
1. Study Identification
Unique Protocol Identification Number
NCT02549768
Brief Title
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
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Neoplasms
Keywords
Dexmedetomidine, Pituitary, Transsphenoidal, Cortisol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Use of dexmedetomidine during surgery (1 mcg/kg in 10 minutes, then infusion at 0.7 mcg/kg/h)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9%
Other Intervention Name(s)
Saline solution
Intervention Description
Sodium chloride 0.9% with a pump programmed in same way as Dexmedetomidine pump
Primary Outcome Measure Information:
Title
Cortisol plasmatic levels
Description
Venous blood sample
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Adrenocorticotropin hormone
Description
Venous blood sample
Time Frame
One hour after surgery, 24 hours after surgery, 48 hours after surgery
Title
Hemodynamics
Description
Heart rate and arterial pressure
Time Frame
From start of anesthesia to end of anesthesia
Title
Nausea and vomiting
Description
Semiquantitative measure
Time Frame
24 hours after surgery
Title
Pain
Description
By visual analogue scale
Time Frame
24 hours after surgery
Title
Patient comfort
Description
Scale ranging from 1 (very unsatisfied) to 5 (very satisfied)
Time Frame
24 hours after discharge from hospital
Title
Diabetes insipidus incidence
Description
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
Title
Cerebrospinal fluid fistula
Description
Clinical diagnosis made by neurosurgeon
Time Frame
3 months after surgery
Title
Cortisol plasmatic levels
Description
Venous blood sample
Time Frame
1 hour after surgery, 48 hours after surgery, 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan C Pedemonte, MD
Phone
56-2-23543270
Email
jcpedemo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Villanueva, MD
Phone
56-2-23543465
Email
pablovillanueva@neurocirugiauc.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Pedemonte, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pablo Villanueva, MD
Organizational Affiliation
Assisstant adjunct professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division de Anestesia - Pontificia Universidad Catolica de Chile
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8330024
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando R Altermatt, MSc
Phone
56-2-23543270
Email
fernando.altermatt@gmail.com
First Name & Middle Initial & Last Name & Degree
Hernan E Auad, MD
Phone
56-2-23543270
Email
hernan_auad@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25517050
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.
Results Reference
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PubMed Identifier
3372683
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. doi: 10.1210/jcem-66-6-1208.
Results Reference
background
PubMed Identifier
19098618
Citation
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.
Results Reference
background
PubMed Identifier
10730549
Citation
Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.
Results Reference
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PubMed Identifier
25493927
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.
Results Reference
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PubMed Identifier
15757125
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.
Results Reference
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PubMed Identifier
16790625
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.
Results Reference
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PubMed Identifier
14740262
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. Erratum In: Acta Neurochir (Wien). 2004 Apr;146(6):433.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery
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