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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anterior Cervical Discectomy and Fusion (ACDF)

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Ketamine
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil Group<br>Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia. | Drug: Remifentanil<br>* Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.<br>|
| Active Comparator: Ketamine and Dexmedetomidine group<br>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<br>* 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.<br>Drug: Dexmedetomidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Unacceptable Movement Under General Anesthesia | 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. | duration of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Stability | Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia | up to 24 hours | 
| Time to Extubation | From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired. | up to 24 hours | 
| Quality of Recovery | ( 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 | 24 hours post-op | 
| Narcotic Consumption | all narcotics and pain medication consumed by subject in the recovery room until discharged will be recorded and compared among 2 study groups. | 24 hours |