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

Phase 4
Completed
Conditions
Anterior Cervical Discectomy and Fusion (ACDF)
Interventions
Registration Number
NCT03643796
Lead Sponsor
University of Arkansas
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 available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Remifentanil GroupRemifentanilRemifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.
Ketamine and Dexmedetomidine groupKetaminedexmedetomidine 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.
Ketamine and Dexmedetomidine groupDexmedetomidinedexmedetomidine 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.
Primary Outcome Measures
NameTimeMethod
Incidence of Unacceptable Movement Under General Anesthesiaduration 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 Outcome Measures
NameTimeMethod
Hemodynamic Stabilityup to 24 hours

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

Time to Extubationup to 24 hours

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

Narcotic Consumption24 hours

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

Quality of Recovery24 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

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

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