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

NCT03643796 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-09-18

Study results available
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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)

Interventions

DRUG

Remifentanil

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

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Mohamed Abdeldayem, MD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-15
Primary Completion
2022-07-05
Completion
2022-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643796 on ClinicalTrials.gov