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

Anterior Cervical Discectomy and Fusion (ACDF) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643796
• Other study ID #: 207374
• Status: Completed
• Phase: Phase 4
• Start date: July 15, 2018
• Est. completion date: July 5, 2022

Study information

• Verified date: April 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 5, 2022
• Est. primary completion date: July 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cervical Discectomy and Fusion (ACDF)

Intervention

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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hemodynamic Stability	Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia	up to 24 hours
Secondary	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
Secondary	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
Secondary	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