NCT03236727

Brief Summary

Intravenous anesthetic agents as far as inhaled agents produce a dose depended increase in latency and decrease in amplitude of SomatoSensory Evoked Potential (SSEP). Dexmetedomidine, a highly selective a2 adrenergic agonist, not only minimizes the anesthetic agents but also the opioids, reducing the analgesic demands. The effect of dexmedetomidine on SSEP has not been elucidated. We aimed to investigate alterations on somatosensory SSEP in adults during posterior spinal fusion surgery before and after Dexmedetomidine administration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2014

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

Study Start

First participant enrolled

March 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

July 25, 2017

Last Update Submit

August 1, 2017

Conditions

Spinal Fusion

Keywords

Dexmedetomidine, spinal fusion, SSEP

Outcome Measures

Primary Outcomes (1)

  • SSEPs

    measurement of SSEPs parameters regarding the baseline.

    10 min after starting infusion of dexmedetomidine

Study Arms (2)

Control

NO INTERVENTION

Data of SSEPs (amplitude and latency) before dexmedetomidine infusion.

Dexmedetomidine

ACTIVE COMPARATOR

Data of SSEPs (amplitude and latency) after dexmedetomidine infusion.

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Changes of both amplitude and latency of SSEPs during dexmedetomidine infusion.

Also known as: Control-no dexmedetomidine
Dexmedetomidine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ASA physical status 1-3

You may not qualify if:

  • Patients with ASA physical status \>3,
  • Body Mass Index (BMI) over 30,
  • indication for rapid sequence induction,
  • any contraindication for receiving b-blocker,
  • Glasgow Coma Scale (GCS) \<13,
  • history of drug abuse,
  • neurologic deficit or preoperatively foreseen delayed extubation,
  • preoperative heart rate\<45.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 2, 2017

Study Start

March 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

August 3, 2017

Record last verified: 2017-08