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

• Sponsor: The Cooper Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT03996148
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 3
• Actual Duration (Months): 11.7
• Patients Per Site Per Month: 1.8

Study Details

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

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 Design

• Study Type: Interventional
• 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: Sep 29, 2017
• Actual Primary Completion Date: Sep 19, 2018
• Actual Study Completion Date: Sep 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; 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 Suprane Precedex
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

Outcome Measures

Primary Outcome Measures

1. Time to First Neurological Exam [up to 1 hour after emergence from general anesthesia.]

   Time to first neurological exam after emergence from general anesthesia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Cooper University Hospital	Camden	New Jersey	United States	08103

Sponsors and Collaborators

• The Cooper Health System

Investigators

• Study Director: Rhea Temmermand, CRNA, Cooper University Healthcare

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 3, 2019

More Information

Publications

None provided.

• Responsible Party: Rhea Temmermand, Principal Investigator, The Cooper Health System
• ClinicalTrials.gov Identifier: NCT03996148
• Other Study ID Numbers: 17-108
• First Posted: Jun 24, 2019
• Last Update Posted: Apr 6, 2022
• Last Verified: Mar 1, 2022

• 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: Carotid Stenosis; Dexmedetomidine; Remifentanil; Propofol; Desflurane

Study Results

Participant Flow

Arm/Group Title	Remifentanil, Propofol, and Desflurane	Remifentanil, Dexmedetomidine, and Desflurane	Remifentanil and Desflurane
Arm/Group Description	Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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	Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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	Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
Period Title: Overall Study
STARTED	7	7	7
COMPLETED	7	6	7
NOT COMPLETED	0	1	0

Baseline Characteristics

Arm/Group Title	Remifentanil, Propofol, and Desflurane	Remifentanil, Dexmedetomidine, and Desflurane	Remifentanil and Desflurane	Total
Arm/Group Description	Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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	Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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	Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable	Total of all reporting groups
Overall Participants	7	6	7	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (4)	73 (12)	70 (10)	71 (10)
Sex: Female, Male (Count of Participants)
Female	1 14.3%	2 33.3%	1 14.3%	4 20%
Male	6 85.7%	4 66.7%	6 85.7%	16 80%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	6 100%	7 100%	20 100%
Preoperative Short Blessed Test (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	4	0	5	4
Confusion Assessment Method (3D CAM) (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil, Propofol, and Desflurane	Remifentanil, Dexmedetomidine, and Desflurane	Remifentanil and Desflurane
Arm/Group Description	Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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	Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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	Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
Measure Participants	7	6	7
Mean (Standard Deviation) [Minutes]	9 (4)	7 (4)	7 (3)

Adverse Events

Time Frame	30 days after enrollment
Arm/Group Title	Remifentanil, Propofol, and Desflurane		Remifentanil, Dexmedetomidine, and Desflurane		Remifentanil and Desflurane
Arm/Group Description	Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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		Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. 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		Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
All Cause Mortality
	Remifentanil, Propofol, and Desflurane		Remifentanil, Dexmedetomidine, and Desflurane		Remifentanil and Desflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Remifentanil, Propofol, and Desflurane		Remifentanil, Dexmedetomidine, and Desflurane		Remifentanil and Desflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		1/7 (14.3%)		0/7 (0%)
Nervous system disorders
SAE	0/7 (0%)		1/7 (14.3%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Remifentanil, Propofol, and Desflurane		Remifentanil, Dexmedetomidine, and Desflurane		Remifentanil and Desflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.