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

Ketamine

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.

Intervention / Treatment

  • Remifentanil (DRUG)
    Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.
  • Ketamine (DRUG)
    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.
  • Dexmedetomidine (DRUG)
    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.

Condition or Disease

  • Anterior Cervical Discectomy and Fusion (ACDF)

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 32 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Jul 15, 2018 ACTUAL
    Primary Completion: Jul 05, 2022 ACTUAL
    Completion Date: Jul 05, 2022 ACTUAL
    Study First Posted: Aug 23, 2018 ACTUAL
    Results First Posted: Sep 18, 2023 ACTUAL
    Last Updated: Sep 14, 2023

    Sponsors / Collaborators

    Lead Sponsor: University of Arkansas
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Little Rock, Arkansas, USA

    Participant Groups

    • Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 Outcomes

    • Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia

    • From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired.

    • ( Modified Quality of Recovery score, QoR-15) is a psychometric assessment of recovery from general anesthesia.Answers of 15 questions are given scores from 1 to 10 on a Likert scale. The score ranges from 0 to 150. The questionnaire is designed to assess the emotional state, physical comfort, psychological support, physical independence, and pain. A higher score indicates a better outcome

    • all narcotics and pain medication consumed by subject in the recovery room until discharged will be recorded and compared among 2 study groups.

    More Details

    NCT Number: NCT03643796
    Other IDs: 207374
    Study URL: https://clinicaltrials.gov/study/NCT03643796
    Last updated: Sep 29, 2023