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

NCT03996148 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-108
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Time to First Neurological Exam

  Time to first neurological exam after emergence from general anesthesia

  up to 1 hour after emergence from general anesthesia.

Study Arms (3)

Remifentanil, Propofol, and Desflurane

ACTIVE COMPARATOR

Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured.

Drug: Remifentanil, Propofol, and Desflurane

Remifentanil, Dexmedetomidine, and Desflurane

ACTIVE COMPARATOR

Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured.

Drug: Remifentanil, Dexmedetomidine, and Desflurane

Remifentanil and Desflurane

ACTIVE COMPARATOR

Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured.

Drug: Remifentanil and Desflurane

Interventions

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

Also known as: Ultiva, Diprivan, Suprane

Remifentanil, Propofol, and Desflurane

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

Also known as: Ultiva, Suprane, Precedex

Remifentanil, Dexmedetomidine, and Desflurane

Remifentanil and Desflurane DRUG

Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable

Also known as: Ultiva, Suprane

Remifentanil and Desflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Having carotid endarterectomy surgery
• Able to undergo a preoperative neurological exam

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Remifentanil; Propofol; Desflurane; Dexmedetomidine

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Imidazoles; Azoles

Results Point of Contact

• Title: Ludmil Mitrev
• Organization: Cooper University Hospital

mitrev-ludmil@cooperhealth.edu

(800) 826-6737

Study Officials

• Rhea Temmermand, CRNA

  Cooper University Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 24, 2019
• Study Start: September 29, 2017
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: April 6, 2022
• Results First Posted: April 6, 2022

Record last verified: 2022-03

Locations

US (1)