Phase 4
N=32
Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
Anterior Cervical Discectomy and Fusion (ACDF)
Bottom Line
View on ClinicalTrials.gov: NCT03643796 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Incidence of Unacceptable Movement Under General Anesthesia — 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Remifentanil (Drug); Ketamine (Drug); Dexmedetomidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Unacceptable Movement Under General Anesthesia |
1; 1 | — |
| SECONDARY Hemodynamic Stability |
4; 5 | — |
| SECONDARY Time to Extubation |
12; 18 | — |
| SECONDARY Quality of Recovery |
122; 127 | — |
| SECONDARY Narcotic Consumption |
12.7; 11.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03643796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.