Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques
Primary Purpose
Carotid Artery Stenosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Remifentanil, Propofol, and Desflurane
Remifentanil, Dexmedetomidine, and Desflurane
Remifentanil and Desflurane
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Stenosis
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
Sites / Locations
- Cooper University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Remifentanil, Propofol, and Desflurane
Remifentanil, Dexmedetomidine, and Desflurane
Remifentanil and Desflurane
Arm Description
Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.
Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.
Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.
Outcomes
Primary Outcome Measures
Time to First Neurological Exam
Time to first neurological exam after emergence from general anesthesia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03996148
Brief Title
Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
September 19, 2018 (Actual)
Study Completion Date
September 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cooper Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil, Propofol, and Desflurane
Arm Type
Active Comparator
Arm Description
Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.
Arm Title
Remifentanil, Dexmedetomidine, and Desflurane
Arm Type
Active Comparator
Arm Description
Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.
Arm Title
Remifentanil and Desflurane
Arm Type
Active Comparator
Arm Description
Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.
Intervention Type
Drug
Intervention Name(s)
Remifentanil, Propofol, and Desflurane
Other Intervention Name(s)
Ultiva, Diprivan, Suprane
Intervention Description
Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC
Intervention Type
Drug
Intervention Name(s)
Remifentanil, Dexmedetomidine, and Desflurane
Other Intervention Name(s)
Ultiva, Suprane, Precedex
Intervention Description
Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC
Intervention Type
Drug
Intervention Name(s)
Remifentanil and Desflurane
Other Intervention Name(s)
Ultiva, Suprane
Intervention Description
Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
Primary Outcome Measure Information:
Title
Time to First Neurological Exam
Description
Time to first neurological exam after emergence from general anesthesia
Time Frame
up to 1 hour after emergence from general anesthesia.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhea Temmermand, CRNA
Organizational Affiliation
Cooper University Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
12. IPD Sharing Statement
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Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques
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