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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03236727
Other study ID # GeorgePHT
Secondary ID
Status Completed
Phase Phase 3
First received July 25, 2017
Last updated August 1, 2017
Start date March 2014
Est. completion date June 2016

Study information

Verified date August 2017
Source George Papanicolaou Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
Changes of both amplitude and latency of SSEPs during dexmedetomidine infusion.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
George Papanicolaou Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary SSEPs measurement of SSEPs parameters regarding the baseline. 10 min after starting infusion of dexmedetomidine
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