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

March 16, 2022 updated by: Rhea Temmermand, The Cooper Health System

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other Names:
  • Ultiva
  • Diprivan
  • Suprane
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
Other Names:
  • Ultiva
  • Precedex
  • Suprane
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
Other Names:
  • Ultiva
  • Suprane

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to First Neurological Exam
Time Frame: up to 1 hour after emergence from general anesthesia.
Time to first neurological exam after emergence from general anesthesia
up to 1 hour after emergence from general anesthesia.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cooper Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rhea Temmermand, CRNA, Cooper University Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-108

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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