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

University of Arkansas

Status and phase: Completed; Phase 4

Conditions: Anterior Cervical Discectomy and Fusion (ACDF)

Treatments: Drug: Remifentanil; Drug: Dexmedetomidine; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03643796

207374

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Remifentanil Group

Active Comparator group

Description:

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

Treatment:

Drug: Remifentanil

Ketamine and Dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Ketamine