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Pituitary NeoplasmsPhase 4NCT02549768

Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery

A Phase 4 study testing Dexmedetomidine and Sodium Chloride 0.9% in people with Pituitary Neoplasms, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Pituitary Neoplasms
What is being tested?
Dexmedetomidine and Sodium Chloride 0.9%
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChile
Study dates
Sep 2015to Aug 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Cushing disease.
  • Pituitary apoplexy.
  • Craniopharyngioma.
  • Chronic corticosteroid use.
  • Hemodynamic instability.
  • Altered consciousness (Glasgow Coma Scale score less than 15).
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Juan C Pedemonte, MD contact

56-2-23543270

jcpedemo@gmail.com

Pablo Villanueva, MD contact

56-2-23543465

pablovillanueva@neurocirugiauc.cl

Chile1 site, 1 recruiting

  • Division de Anestesia - Pontificia Universidad Catolica de Chile

    Santiago, Santiago Metropolitan, 8330024

    Fernando R Altermatt, MSc, 56-2-23543270, fernando.altermatt@gmail.com

    Hernan E Auad, MD, 56-2-23543270, hernan_auad@hotmail.com

    Recruiting

Other trials in Chile

About this study

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

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

Read the 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.

Being tested
Dexmedetomidine, Sodium Chloride 0.9%
Keywords
Dexmedetomidine, Pituitary, Transsphenoidal, Cortisol
Medical subject headings
Pituitary Neoplasms, Pituitary Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex

    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%Drug

    Also called Saline solution

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

Study groups in NCT02549768
Study groupRoleWhat they receive
DexmedetomidineActive comparatorUse of dexmedetomidine during surgery (1 mcg/kg in 10 minutes, then infusion at 0.7 mcg/kg/h)
Receives: Drug: Dexmedetomidine
PlaceboPlacebo comparatorUse 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.
Receives: Drug: Sodium Chloride 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cortisol plasmatic levels

    Venous blood sample

    Measured: 24 hours after surgery

Secondary outcomes (8)

  1. Adrenocorticotropin hormone

    Venous blood sample

    Measured: One hour after surgery, 24 hours after surgery, 48 hours after surgery

  2. Hemodynamics

    Heart rate and arterial pressure

    Measured: From start of anesthesia to end of anesthesia

  3. Nausea and vomiting

    Semiquantitative measure

    Measured: 24 hours after surgery

  4. Pain

    By visual analogue scale

    Measured: 24 hours after surgery

  5. Patient comfort

    Scale ranging from 1 (very unsatisfied) to 5 (very satisfied)

    Measured: 24 hours after discharge from hospital

  6. 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)

    Measured: 24 hours after surgery and 3 months after surgery

  7. Cerebrospinal fluid fistula

    Clinical diagnosis made by neurosurgeon

    Measured: 3 months after surgery

  8. Cortisol plasmatic levels

    Venous blood sample

    Measured: 1 hour after surgery, 48 hours after surgery, 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJul 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02549768
Sponsor's protocol ID
15-095
Status last verified
Oct 2016
First submitted
6 Sep 2015
Last updated
12 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25517050

  • 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.

    PubMed 3372683

  • 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.

    PubMed 19098618

  • Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.

    PubMed 10730549

  • 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.

    PubMed 25493927

  • 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.

    PubMed 15757125

  • 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.

    PubMed 16790625

  • 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.

    PubMed 14740262

  • 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.

    PubMed 22824921

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Sodium Chloride 0.9% in people with Pituitary Neoplasms, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Juan C Pedemonte, MD (56-2-23543270, jcpedemo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cortisol plasmatic levels (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02549768, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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