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

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ClinicalTrials.gov Identifier: NCT03996148
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Rhea Temmermand, The Cooper Health System

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.

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Drug: Remifentanil, Propofol, and Desflurane Drug: Remifentanil, Dexmedetomidine, and Desflurane Drug: Remifentanil and Desflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : September 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Remifentanil, Propofol, and Desflurane
Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.
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

Active Comparator: Remifentanil, Dexmedetomidine, and Desflurane
Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.
Drug: 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

Active Comparator: Remifentanil and Desflurane
Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.
Drug: Remifentanil and Desflurane
Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable




Primary Outcome Measures :
  1. Time to first neurological exam [ Time Frame: Time (minutes) to first neurological exam immediately after emergence from general anesthesia. ]
    Time to first neurological exam after emergence from general anesthesia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996148


Locations
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United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System

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Responsible Party: Rhea Temmermand, Principal Investigator, The Cooper Health System
ClinicalTrials.gov Identifier: NCT03996148     History of Changes
Other Study ID Numbers: 17-108
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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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

Additional relevant MeSH terms:
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Carotid Stenosis
Neurotransmitter Agents
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dexmedetomidine
Remifentanil
Propofol
Anesthetics
Desflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid