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Clinical Trials/NCT03643796
NCT03643796
Completed
Phase 4

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

University of Arkansas1 site in 1 country32 target enrollmentJuly 15, 2018

Overview

Phase
Phase 4
Intervention
Remifentanil
Conditions
Anterior Cervical Discectomy and Fusion (ACDF)
Sponsor
University of Arkansas
Enrollment
32
Locations
1
Primary Endpoint
Incidence of Unacceptable Movement Under General Anesthesia
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2018
End Date
July 5, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

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: Remifentanil

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.

Intervention: Ketamine

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.

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

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

  • Hemodynamic Stability(up to 24 hours)
  • Time to Extubation(up to 24 hours)
  • Narcotic Consumption(24 hours)
  • Quality of Recovery(24 hours post-op)

Study Sites (1)

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