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Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery

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ClinicalTrials.gov Identifier: NCT03643796
Recruitment Status : Suspended (COVID-19, loss of research facilitators)
First Posted : August 23, 2018
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE July 5, 2018
First Posted Date  ICMJE August 23, 2018
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • 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
  • 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.
  • Quality of recovery [ Time Frame: 24 hours post-op ]
    Quality of Recovery questionnaire
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
Official Title  ICMJE 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
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.
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 Anterior Cervical Discectomy and Fusion (ACDF)
Intervention  ICMJE
  • Drug: Remifentanil
    Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Remifentanil
  • 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.

    Interventions:
    • Drug: Ketamine
    • Drug: Dexmedetomidine
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 Suspended
Estimated Enrollment  ICMJE
 (submitted: October 28, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
80
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (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 NCT03643796
Other Study ID Numbers  ICMJE 207374
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: Undecided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Abdeldayem, MD University of Arkansas
PRS Account University of Arkansas
Verification Date April 2021

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