Phase 4 N=21 Randomized Single-blind Treatment

Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques

Carotid Artery Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT03996148 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Apr 2022

Primary outcome: Primary: Time to First Neurological Exam — 9; 7; 7 Minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Remifentanil, Propofol, and Desflurane (Drug); Remifentanil, Dexmedetomidine, and Desflurane (Drug); Remifentanil and Desflurane (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cooper Health System
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Neurological Exam	9; 7; 7	—

Summary

The objective of this pilot study is to analyze the differences in time to first postoperative neurological examination (cranial nerve XII - tongue movement, movement of extremities) and intraoperative hemodynamic stability with three different general anesthetic techniques that are used for carotid endarterectomy. Carotid endarterectomy surgery removes the plaque and stenosis but has a 1-3% risk of periprocedural stroke or death. The ability to detect neurological abnormalities early after surgery is vital in this patient population to facilitate timely additional diagnostics or interventions if a potential stroke is detected. Anesthetic techniques that facilitate an earlier reliable neurological exam will thus greatly benefit this surgical patient population. The primary objective of this pilot study is to determine the time difference from end of surgery to first neurologic exam between three commonly used anesthetic methods for carotid endareterectomy.

Eligibility Criteria

Inclusion Criteria

18 years of age and older
Having carotid endarterectomy surgery
Able to undergo a preoperative neurological exam

Exclusion Criteria

Pregnant patients
Prisoners
Patients with dementia or reduced mental status acute or chronic
Known brain tumor or head trauma
Known severe, uncorrected coronary artery disease (CAD)
Ejection fraction (EF) less than 15%
Patients with intraaortic ballon pump (IABP) or other mechanical circulatory assist device
Patients with severe chronic obstructive pulmonary disease (COPD)
Combined surgical procedures (CABG and CAD)
Patients with uncontrolled or severe anxiety requiring benzodiazepine administration
Patients with history of difficult airway
Sedation other than propofol, dexmedetomidine or volatile anesthetic agent (VAA) is needed for patient (i.e. ketamine in patients with history of neuropathic pain)
Intubated or unconscious patients
Patients on methadone or fentanyl patch
Patients with known unusual or extreme anesthetic requirements
Patients who would require an unusual amount of narcotic to control pain
Patients having endarterectomy wherein surgeon requests local-regional anesthesia only
Patients with known history of prolonged emergence from anesthesia
Morbidly obese patients (BMI >40)
Patients with scalp or forehead defects that prohibit application of BIS monitor strip

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03996148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.