SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion

Spinal Fusion Clinical Trial

Official title:

SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236727
• Other study ID #: GeorgePHT
• 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
• 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.

Related Conditions & MeSH terms

• Spinal Fusion

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