Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Remifentanil Group Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia. |
Drug: Remifentanil
Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.
|
| Active Comparator: Ketamine and Dexmedetomidine group 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
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.
|
Outcome Measures
Primary Outcome Measures
- Incidence of unacceptable movement under general anesthesia [duration 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
- Hemodynamic stability [up to 24 hours]
Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia
- Time to extubation [up to 24 hours]
From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired.
- Quality of recovery [24 hours post-op]
Quality of Recovery questionnaire
- Narcotic Consumption [24 hours]
all narcotics and pain medication consumed by subject in the recovery room until discharged will be recorded and compared among 2 study groups.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
Sponsors and Collaborators
- University of Arkansas
Investigators
- Principal Investigator: Mohamed Abdeldayem, MD, University of Arkansas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 207374