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

NCT03643796 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 207374
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cervical Discectomy and Fusion (ACDF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hemodynamic Stability

  up to 24 hours

• Time to Extubation

  up to 24 hours

• Quality of Recovery

  24 hours post-op

• Narcotic Consumption

  24 hours

Study Arms (2)

Remifentanil Group

ACTIVE COMPARATOR

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

Drug: Remifentanil

Ketamine and Dexmedetomidine group

ACTIVE COMPARATOR

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; Drug: Dexmedetomidine

Interventions

Remifentanil DRUG

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

Remifentanil Group

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.

Ketamine and Dexmedetomidine group

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.

Ketamine and Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18- to 80-years old
• ASA 1, 2, 3
• or 2 levels ACDF

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

Remifentanil; Ketamine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles

Results Point of Contact

• Title: Mohamed Abdeldayem
• Organization: University of Arkansas for Medical Sciences

Maabdeldayem@uams.edu

2244279747

Study Officials

• Mohamed Abdeldayem, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 23, 2018
• Study Start: July 15, 2018
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-04

Locations

US (1)