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Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
Phase 4 trial testing Remifentanil in Anterior Cervical Discectomy and Fusion (ACDF) in 32 participants. Completed in 5 July 2022.
| Lead sponsor | University of Arkansas |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 15 July 2018 |
| Primary completion | 5 July 2022 |
| Estimated completion | 5 July 2022 |
| Sites | 1 location across United States |
University of Arkansas
Adults 18 to 80, any sex, with Anterior Cervical Discectomy and Fusion (ACDF). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Remifentanil Group | 1 | |
| Ketamine and Dexmedetomidine Group | 1 |
Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia
| Group | Value | 95% CI |
|---|---|---|
| Remifentanil Group | 4 | |
| Ketamine and Dexmedetomidine Group | 5 |
From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired.
| Group | Value | 95% CI |
|---|---|---|
| Remifentanil Group | 12 | ± 7 |
| Ketamine and Dexmedetomidine Group | 18 | ± 7 |
( Modified Quality of Recovery score, QoR-15) is a psychometric assessment of recovery from general anesthesia.Answers of 15 questions are given scores from 1 to 10 on a Likert scale. The score ranges from 0 to 150. The questionnaire is designed to assess the emotional state, physical comfort, psychological support, physical independence, and pain. A higher score indicates a better outcome
| Group | Value | 95% CI |
|---|---|---|
| Ketamine and Dexmedetomidine Group | 122 | ± 7 |
| Remifentanil Group | 127 | ± 8 |
all narcotics and pain medication consumed by subject in the recovery room until discharged will be recorded and compared among 2 study groups.
| Group | Value | 95% CI |
|---|---|---|
| Remifentanil Group | 12.7 | ± 2.4 |
| Ketamine and Dexmedetomidine Group | 11.5 | ± 2.7 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing