CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Remifentanil, Propofol, and Desflurane +2 moredrug
Likely dose
Remifentanil, Propofol, and Desflurane 0.05 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03996148
NCT03996148Phase 4Completed

Time to Post-Anesthesia Neurological Evaluation and Hemodynamic Stability in Carotid Endarterectomy Comparing Three General Anesthetic Techniques Targeted to a Preset Bispectral Index Value: a Pilot Study

The Cooper Health System·interventional·Posted Jun 24, 2019·Updated Apr 6, 2022

In Brief

A Phase 4 clinical trial evaluating Remifentanil, Propofol, and Desflurane, Remifentanil, Dexmedetomidine, and Desflurane, and 1 other intervention for Carotid Artery Stenosis. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 24, 2019
Enrollment StartSep 29, 2017
Primary CompletionSep 19, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.0 years ago

Interventions

Remifentanil, Propofol, and Desfluranedrug

Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC

Remifentanil, Dexmedetomidine, and Desfluranedrug

Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC

Remifentanil and Desfluranedrug

Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable