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Narcotic Free TIVA (Total Intravenous Anesthesia) and the Incidence of Unacceptable Movements Under General Anesthesia During ACDF (Anterior Cervical Discectomy and Fusion) Surgery

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ClinicalTrials.gov Identifier: NCT03643796
Recruitment Status : Enrolling by invitation
First Posted : August 23, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
This study will help the investigators learn more about the best way to give anesthesia for these kinds of surgery. The investigators will be using 2 different groups of medications that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does not. The investigators wish to test whether a narcotic free anesthetic will result in an overall safer surgery, better patient recovery, and satisfaction. The investigators think also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover faster after surgery , and consume less pain medicines in the postoperative period.

Condition or disease Intervention/treatment Phase
Anterior Cervical Discectomy and Fusion (ACDF) Drug: Remifentanil Drug: Ketamine Drug: Dexmedetomidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of a Narcotic Free Total Intravenous Anesthesia on the Outcome and Patient Safety During Anterior Cervical Discectomy and Fusion (ACDF) Surgery: A Randomized Controlled Trial
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Remifentanil Group
Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.
Drug: Remifentanil
Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.

Active Comparator: Ketamine and Dexmedetomidine group

dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.

Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.

Drug: Ketamine
Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.

Drug: Dexmedetomidine
dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.




Primary Outcome Measures :
  1. Incidence of unacceptable movement under general anesthesia [ Time Frame: duration of surgery ]
    Gross visible movement reported by the anesthesiologist or surgical team: bucking, chewing, or reaching to the endotracheal tube and induced by nociception, or head manipulation and positioning by the surgical or anesthesiology team or during a motor evoked potential stimulation.


Secondary Outcome Measures :
  1. Hemodynamic stability [ Time Frame: up to 24 hours ]
    Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia

  2. Time to extubation [ Time Frame: up to 24 hours ]
    From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired.

  3. Quality of recovery [ Time Frame: 24 hours post-op ]
    Quality of Recovery questionnaire

  4. Narcotic Consumption [ Time Frame: 24 hours ]
    all narcotics and pain medication consumed by subject in the recovery room until discharged will be recorded and compared among 2 study groups.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Men and women 18- to 80-years old
  • ASA 1, 2, 3
  • 1 or 2 levels ACDF

Exclusion Criteria

  • ASA 4
  • Seizure disorders
  • Chronic narcotic use
  • Opiate abuse
  • Major cardiac comorbidity, or significantly elevated blood pressure
  • Known hypersensitivity to fentanyl analogs, ketamine, or propofol injectable emulsions.
  • Known allergy to eggs, egg products, soybeans, or soy products

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): NCT03643796


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Mohamed Abdeldayem, MD University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03643796     History of Changes
Other Study ID Numbers: 207374
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Anesthetics
Ketamine
Dexmedetomidine
Remifentanil
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Analgesics, Opioid