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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil, Propofol, and Desflurane | Active Comparator | Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. |
|
| Remifentanil, Dexmedetomidine, and Desflurane | Active Comparator | Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. |
|
| Remifentanil and Desflurane | Active Comparator | Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil, Propofol, and Desflurane | Drug | Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rhea Temmermand, CRNA | Cooper University Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remifentanil, Propofol, and Desflurane | Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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 |
| FG001 | Remifentanil, Dexmedetomidine, and Desflurane | Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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 |
| FG002 | Remifentanil and Desflurane | Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remifentanil, Propofol, and Desflurane | Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Neurological Exam | Time to first neurological exam after emergence from general anesthesia | Posted | Mean | Standard Deviation | Minutes | up to 1 hour after emergence from general anesthesia. |
|
30 days after enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remifentanil, Propofol, and Desflurane | Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAE | Nervous system disorders | Systematic Assessment | Not study related, stroke |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ludmil Mitrev | Cooper University Hospital | (800) 826-6737 | mitrev-ludmil@cooperhealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2019 | Mar 9, 2022 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D015742 | Propofol |
| D000077335 | Desflurane |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Remifentanil, Dexmedetomidine, and Desflurane | Drug | 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 | Drug | Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable |
|
|
| BG001 |
| Remifentanil, Dexmedetomidine, and Desflurane |
Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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 |
| BG002 | Remifentanil and Desflurane | Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Preoperative Short Blessed Test | The Short Blessed Test (SBT) is used as a screening test for cognitive changes. There is no unabbreviated scale name. The SBT is a sum of wrong answers (errors) on 6 verbal questions, where each of these is multiplied by a weighting factor. The total score is a whole number ranging from 0 to 28. Based on clinical research findings, the following cut points have been described: 0-4: normal cognition; 5-9: questionable impairment; 10 or more: impairment consistent with dementia or dementing disorder. | Median | Inter-Quartile Range | units on a scale |
|
| Confusion Assessment Method (3D CAM) | The 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) is a brief verbal assessment tool for delirium via a short interview of 22 questions. If any answer to the questions is wrong or an observational item is present, a checkmark is applied against one of 4 features that characterize delirium: 1) acute onset or fluctuating course; 2) inattention; 3) disorganized thinking; and 4) altered level of consciousness. If at least one checkmark is present in both domains 1 and 2, and at least one in EITHER 3 or 4, delirium is present. Data is # of subjects WITH baseline delirium. | Count of Participants | Participants |
|
| OG002 | Remifentanil and Desflurane | Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Remifentanil, Dexmedetomidine, and Desflurane | Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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 | 0 | 7 | 1 | 7 | 0 | 7 |
| EG002 | Remifentanil and Desflurane | Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable | 0 | 7 | 0 | 7 | 0 | 7 |
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| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| Male |
|