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
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Neoplasms||Drug: Dexmedetomidine Drug: Sodium Chloride 0.9%||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Active Comparator: Dexmedetomidine
Use of dexmedetomidine during surgery (1 mcg/kg in 10 minutes, then infusion at 0.7 mcg/kg/h)
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
- Cortisol plasmatic levels [ Time Frame: 24 hours after surgery ]Venous blood sample
- Adrenocorticotropin hormone [ Time Frame: One hour after surgery, 24 hours after surgery, 48 hours after surgery ]Venous blood sample
- Hemodynamics [ Time Frame: From start of anesthesia to end of anesthesia ]Heart rate and arterial pressure
- Nausea and vomiting [ Time Frame: 24 hours after surgery ]Semiquantitative measure
- Pain [ Time Frame: 24 hours after surgery ]By visual analogue scale
- Patient comfort [ Time Frame: 24 hours after discharge from hospital ]Scale ranging from 1 (very unsatisfied) to 5 (very satisfied)
- 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)
- Cerebrospinal fluid fistula [ Time Frame: 3 months after surgery ]Clinical diagnosis made by neurosurgeon
- Cortisol plasmatic levels [ Time Frame: 1 hour after surgery, 48 hours after surgery, 3 months after surgery ]Venous blood sample
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
|Contact: Juan C Pedemonte, MDemail@example.com|
|Contact: Pablo Villanueva, MDfirstname.lastname@example.org|
|Division de Anestesia - Pontificia Universidad Catolica de Chile||Recruiting|
|Santiago, Region Metropolitana, Chile, 8330024|
|Contact: Fernando R Altermatt, MSc 56-2-23543270 email@example.com|
|Contact: Hernan E Auad, MD 56-2-23543270 firstname.lastname@example.org|
|Principal Investigator:||Juan C Pedemonte, MD||Physician|
|Principal Investigator:||Pablo Villanueva, MD||Assisstant adjunct professor|