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Completed

NCT Number: NCT03643796

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

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.

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Key information

Conditions

Anterior Cervical Discectomy and Fusion (ACDF)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

    ( 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

  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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2018
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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