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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03996148
Other study ID # 17-108
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 29, 2017
Est. completion date September 19, 2018

Study information

Verified date March 2022
Source The Cooper Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Carotid endarterectomy reduces the incidence of stroke in people with symptomatic, severe carotid artery stenosis. However, there are risks associated with this procedure such as stroke from carotid clamping with poor collateral brain circulation or embolization of carotid plaque debris (Sheth, 2017). Few surgeons monitor the brain during the procedure using SSEP or EEG, as most rely on intraoperative blood pressure management, shunting, and postoperative neurological exam (De Santis, 2016; Kobayashi, 2011). A Cochrane review of regional versus general anesthesia for carotid endarterectomy reveals no significant difference in outcomes (Vaniyaping, 2013). It is common practice at Cooper Hospital to deliver general anesthesia. The general anesthetic given may affect the length of time to first post-operative neurological response and the hemodynamic stability, though this is not well studied. A search in PubMed in April 2017 for "carotid endarterectomy AND (general anesthesia OR total intravenous anesthesia OR regional anesthesia) AND neurologic exam" ("endarterectomy, carotid"[MeSH Terms] OR ("endarterectomy"[All Fields] AND "carotid"[All Fields]) OR "carotid endarterectomy"[All Fields] OR ("carotid"[All Fields] AND "endarterectomy"[All Fields])) AND (("general anaesthesia"[All Fields] OR "anesthesia, general"[MeSH Terms] OR ("anesthesia"[All Fields] AND "general"[All Fields]) OR "general anesthesia"[All Fields] OR ("general"[All Fields] AND "anesthesia"[All Fields])) OR (total[All Fields] AND ("intravenous anaesthesia"[All Fields] OR "anesthesia, intravenous"[MeSH Terms] OR ("anesthesia"[All Fields] AND "intravenous"[All Fields]) OR "intravenous anesthesia"[All Fields] OR ("intravenous"[All Fields] AND "anesthesia"[All Fields]))) OR ("regional anaesthesia"[All Fields] OR "anesthesia, conduction"[MeSH Terms] OR ("anesthesia"[All Fields] AND "conduction"[All Fields]) OR "conduction anesthesia"[All Fields] OR ("regional"[All Fields] AND "anesthesia"[All Fields]) OR "regional anesthesia"[All Fields])) AND (neurologic[All Fields] AND exam[All Fields]) revealed no studies comparing anesthetic types and time to first post-operative neurological response in this surgical population. Through anecdotal experience at Cooper Hospital, patients are noted to emerge faster and follow commands sooner when not given preoperative midazolam and given a combined Total Intravenous Anesthetic (TIVA) and volatile inhalational anesthetic technique titrated to a bispectral index (BIS) of 50-60. Ruling out anesthetic causes of abnormal neurological function is vital in this patient population. Neurological dysfunction that is surgical in nature may require early intervention such as surgical reexploration or CT scan. "Time is brain", and a few minutes difference is enough to cause permanent neurological damage if a progressing stroke is not quickly identified. Anesthetic techniques that demonstrate a quicker return to baseline neurological function will greatly benefit this surgical patient population.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date September 19, 2018
Est. primary completion date September 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 18 years of age and older 2. Having carotid endarterectomy surgery 3. Able to undergo a preoperative neurological exam Exclusion Criteria: 1. Pregnant patients 2. Prisoners 3. Patients with dementia or reduced mental status acute or chronic 4. Known brain tumor or head trauma 5. Known severe, uncorrected coronary artery disease (CAD) 6. Ejection fraction (EF) less than 15% 7. Patients with intraaortic ballon pump (IABP) or other mechanical circulatory assist device 8. Patients with severe chronic obstructive pulmonary disease (COPD) 9. Combined surgical procedures (CABG and CAD) 10. Patients with uncontrolled or severe anxiety requiring benzodiazepine administration 11. Patients with history of difficult airway 12. Sedation other than propofol, dexmedetomidine or volatile anesthetic agent (VAA) is needed for patient (i.e. ketamine in patients with history of neuropathic pain) 13. Intubated or unconscious patients 14. Patients on methadone or fentanyl patch 15. Patients with known unusual or extreme anesthetic requirements 16. Patients who would require an unusual amount of narcotic to control pain 17. Patients having endarterectomy wherein surgeon requests local-regional anesthesia only 18. Patients with known history of prolonged emergence from anesthesia 19. Morbidly obese patients (BMI >40) 20. Patients with scalp or forehead defects that prohibit application of BIS monitor strip

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remifentanil, Propofol, and Desflurane
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 Desflurane
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 Desflurane
Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable

Locations

Country Name City State
United States Cooper University Hospital Camden New Jersey

Sponsors (1)

Lead Sponsor Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Neurological Exam Time to first neurological exam after emergence from general anesthesia up to 1 hour after emergence from general anesthesia.
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