NCT02549768

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

September 6, 2015

Last Update Submit

October 10, 2016

Conditions

Pituitary Neoplasms

Keywords

DexmedetomidinePituitaryTranssphenoidalCortisol

Outcome Measures

Primary Outcomes (1)

  • Cortisol plasmatic levels

    Venous blood sample

    24 hours after surgery

Secondary Outcomes (8)

  • Adrenocorticotropin hormone

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

  • Hemodynamics

    From start of anesthesia to end of anesthesia

  • Nausea and vomiting

    24 hours after surgery

  • Pain

    24 hours after surgery

  • Patient comfort

    24 hours after discharge from hospital

  • +3 more secondary outcomes

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Use of dexmedetomidine during surgery (1 mcg/kg in 10 minutes, then infusion at 0.7 mcg/kg/h)

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

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%

Interventions

DexmedetomidineDRUG

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.

Also known as: Precedex
Dexmedetomidine
Sodium Chloride 0.9%DRUG

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

Also known as: Saline solution
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division de Anestesia - Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

Related Publications (9)

  • 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.

    PMID: 25517050BACKGROUND

  • 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.

    PMID: 3372683BACKGROUND

  • 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.

    PMID: 19098618BACKGROUND

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

    PMID: 10730549BACKGROUND

  • 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.

    PMID: 25493927BACKGROUND

  • 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.

    PMID: 15757125BACKGROUND

  • 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.

    PMID: 16790625BACKGROUND

  • 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.

    PMID: 14740262BACKGROUND

  • 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.

    PMID: 22824921BACKGROUND

MeSH Terms

Conditions

Pituitary NeoplasmsPituitary Diseases

Interventions

DexmedetomidineSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Juan C Pedemonte, MD

    Physician

    PRINCIPAL INVESTIGATOR

  • Pablo Villanueva, MD

    Assisstant adjunct professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan C Pedemonte, MD

CONTACT

56-2-23543270jcpedemo@gmail.com

Pablo Villanueva, MD

CONTACT

56-2-23543465pablovillanueva@neurocirugiauc.cl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

CL(1)