NCT00494832

Brief Summary

The purposes of this study are:

  1. 1.To evaluate the safety and efficacy of Dexmedetomidine as an adjunct for anesthesia during spine surgery and
  2. 2.To investigate the influence of Dexmedetomidine on the evoked potentials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

2.2 years

First QC Date

June 28, 2007

Last Update Submit

September 12, 2012

Conditions

Spine Surgery

Keywords

DexmedetomidineEvoked potentialsSpine surgery

Outcome Measures

Primary Outcomes (1)

  • Change in evoked potentials

    Duration of surgery

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine infusion

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Normal Saline infusion

Drug: Normal Saline

Interventions

DexmedetomidineDRUG

10 minutes loading dose of 0.9 mcg/kg Maintenance dose of 0.6 mcg/kg/hour

Also known as: Dexmedetomidine hydrochloride
Dexmedetomidine
Normal SalineDRUG

10 minutes loading dose of 0.9 mcg/kg Maintenance dose of 0.6 mcg/kg/hour

Also known as: 0.9% Sodium Chloride
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult spine surgery patients requiring evoked potentials monitoring.

You may not qualify if:

  • Age younger than 18 and older than 80 years
  • Patients with moderate neurological deficit
  • ASA grade above 3
  • Any chronic psychiatric disorder
  • Body mass index (BMI) above 35
  • Patients with cortical blindness, cataracts, retinal or optic neuropathy, glaucoma, untreated diabetes, active hepatitis, active coronary artery disease, untreated arrhythmias and patients with renal or hepatic insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Rozet I, Metzner J, Brown M, Treggiari MM, Slimp JC, Kinney G, Sharma D, Lee LA, Vavilala MS. Dexmedetomidine Does Not Affect Evoked Potentials During Spine Surgery. Anesth Analg. 2015 Aug;121(2):492-501. doi: 10.1213/ANE.0000000000000840.

    PMID: 26097987DERIVED

MeSH Terms

Interventions

DexmedetomidineSaline SolutionSodium Chloride

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Irene Rozet, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2007

First Posted

July 2, 2007

Study Start

February 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

US(2)