SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion

August 1, 2017 updated by: Asouhidou Irene, George Papanicolaou Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients 18-75 years old, ASA (physical status classification system) I-III, scheduled for elective posterior spinal fusion surgery were enrolled in this prospective study. After induction in anesthesia, it was applied SSEP monitoring and a baseline test was performed after 15min (in order to wash out the propofol used for induction). Infusion of Dexmedetomidine was started at a bolus dose of 1mcg/Kg following by 0.7mcg/Kg. Bispectral Index (BIS) monitored the depth of anesthesia and an adequate level (40-50) of anesthesia was maintained by sevoflurane. SSEP were recorded intraoperatively from the tibial nerve (P37) and data were analyzed over that period.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ASA physical status 1-3

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Data of SSEPs (amplitude and latency) before dexmedetomidine infusion.
Active Comparator: Dexmedetomidine
Data of SSEPs (amplitude and latency) after dexmedetomidine infusion.
Drug: Dexmedetomidine
Changes of both amplitude and latency of SSEPs during dexmedetomidine infusion.
Other Names:
  • Control-no dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SSEPs
Time Frame: 10 min after starting infusion of dexmedetomidine
measurement of SSEPs parameters regarding the baseline.
10 min after starting infusion of dexmedetomidine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Papanicolaou Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GeorgePHT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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