SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia

NCT02535273

Spinal Diseases Local Anesthesia

UNKNOWN PHASE4

Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring

NCT06210061

Propofol Fentanyl Dexmedetomidine +4 more

COMPLETED NA

Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

NCT06671327

Pain Management Noncardiac Surgery

NOT_YET_RECRUITING PHASE4

Hemodynamic Effects of Fentanyl Vs Dexmedetomidine in Spine Surgery

NCT07238101

Spine Surgery Hemodynamic Stability During Anesthesia

COMPLETED PHASE4

Study of Dexmedetomidine in Spine Surgery

NCT01850017

Collapse of Thoracic Vertebra Collapse of Lumbar Vertebrae

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Fusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control-no dexmedetomidine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No