免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques

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

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.

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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE September 29, 2017
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Carotid Artery Stenosis
Intervention  ICMJE
  • 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
  • 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
  • Drug: Remifentanil and Desflurane
    Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
Study Arms  ICMJE
  • Active Comparator: Remifentanil, Propofol, and Desflurane
    Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.
    Intervention: Drug: Remifentanil, Propofol, and Desflurane
  • Active Comparator: Remifentanil, Dexmedetomidine, and Desflurane
    Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.
    Intervention: Drug: Remifentanil, Dexmedetomidine, and Desflurane
  • Active Comparator: Remifentanil and Desflurane
    Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.
    Intervention: Drug: Remifentanil and Desflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2019) 		21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 19, 2018
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996148
Other Study ID Numbers  ICMJE 17-108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rhea Temmermand, The Cooper Health System
Study Sponsor  ICMJE The Cooper Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Cooper Health System
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯