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Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery

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ClinicalTrials.gov Identifier: NCT02549768
Recruitment Status : Unknown
Verified October 2016 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : September 15, 2015
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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

Condition or disease Intervention/treatment Phase
Pituitary Neoplasms Drug: Dexmedetomidine Drug: Sodium Chloride 0.9% Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dexmedetomidine as Anesthetic Coadjuvant on Plasmatic Cortisol Response in Transsphenoidal Surgery for Pituitary Tumors
Study Start Date : September 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexmedetomidine
Use of dexmedetomidine during surgery (1 mcg/kg in 10 minutes, then infusion at 0.7 mcg/kg/h)
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.
Other Name: Precedex

Placebo Comparator: Placebo
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.
Drug: Sodium Chloride 0.9%
Sodium chloride 0.9% with a pump programmed in same way as Dexmedetomidine pump
Other Name: Saline solution




Primary Outcome Measures :
  1. Cortisol plasmatic levels [ Time Frame: 24 hours after surgery ]
    Venous blood sample


Secondary Outcome Measures :
  1. Adrenocorticotropin hormone [ Time Frame: One hour after surgery, 24 hours after surgery, 48 hours after surgery ]
    Venous blood sample

  2. Hemodynamics [ Time Frame: From start of anesthesia to end of anesthesia ]
    Heart rate and arterial pressure

  3. Nausea and vomiting [ Time Frame: 24 hours after surgery ]
    Semiquantitative measure

  4. Pain [ Time Frame: 24 hours after surgery ]
    By visual analogue scale

  5. Patient comfort [ Time Frame: 24 hours after discharge from hospital ]
    Scale ranging from 1 (very unsatisfied) to 5 (very satisfied)

  6. Diabetes insipidus incidence [ Time Frame: 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)

  7. Cerebrospinal fluid fistula [ Time Frame: 3 months after surgery ]
    Clinical diagnosis made by neurosurgeon

  8. Cortisol plasmatic levels [ Time Frame: 1 hour after surgery, 48 hours after surgery, 3 months after surgery ]
    Venous blood sample



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549768


Contacts
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Contact: Juan C Pedemonte, MD 56-2-23543270 jcpedemo@gmail.com
Contact: Pablo Villanueva, MD 56-2-23543465 pablovillanueva@neurocirugiauc.cl

Locations
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Chile
Division de Anestesia - Pontificia Universidad Catolica de Chile Recruiting
Santiago, Region Metropolitana, Chile, 8330024
Contact: Fernando R Altermatt, MSc    56-2-23543270    fernando.altermatt@gmail.com   
Contact: Hernan E Auad, MD    56-2-23543270    hernan_auad@hotmail.com   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Juan C Pedemonte, MD Physician
Principal Investigator: Pablo Villanueva, MD Assisstant adjunct professor

Publications:

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02549768     History of Changes
Other Study ID Numbers: 15-095
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Pontificia Universidad Catolica de Chile:
Dexmedetomidine
Pituitary
Transsphenoidal
Cortisol

Additional relevant MeSH terms:
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Pituitary Diseases
Pituitary Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Dexmedetomidine
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists