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NCT06096181 · ClinicalTrials.gov registry record · Phase 2
Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT06096181 is a Phase 2 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 13 participants.
The verdict
NCT06096181, a Phase 2 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. The purpose of this study is to compare two combinations of total intravenous anesthetic medications in children with Adolescent Idiopathic Scoliosis having posterior spinal fusion surgery. Participants in the study will be randomly selected to receive either Propofol and Remifentanil or Propofol and Dexmedetomidine as their total intravenous anesthesia (TIVA). TIVA is favored over gas anesthesia because gas anesthesia can affect the neurological monitoring necessary for this surgery. The first combination (Propofol + Remifentanil) is the most common one used for this surgery at our institution, and the second combination (Propofol + Dexmedetomidine) is more commonly used in adult spine surgery. Though Dexmedetomidine is not approved for pediatric use by the FDA, it is widely used in pediatric patients for procedural sedation and surgical anesthesia in the US and worldwide. Both anesthetic combinations are used safely in adult and pediatric patients at our institution. Although remifentanil works fast and is an excellent pain medication during surgery, there are reports that it's use can cause increased pain sensitivity and greater need for narcotic pain medication after surgery. This phenomenon is known as opioid-induced hyperalgesia. The investigators hypothesize that avoiding the use of remifentanil in the TIVA by using dexmedetomidine could avoid OIH and thus result in superior postop pain control. Our study's primary goal is to measure the total opioid consumption on postoperative days (POD)# 0 and 1. Our secondary goals are to measure the pain scores on a visual analog scale (VAS) on POD# 0 and 1, measure the time it takes for participants to move their feet to command when surgery is done, and measure th
Interventions
- DRUG Remifentanil TIVA
- DRUG Dexmedetomidine TIVA
- DRUG Propofol TIVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2024-12-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06096181
The ClinicalTrials.gov registry entry for NCT06096181 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Remifentanil TIVA is the first listed.
NCT06096181 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06096181 about?
NCT06096181 is a clinical study titled "Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery". Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. The purpose of this study is to compare two ...
What is the current status of trial NCT06096181?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2023-12-20. Estimated completion is 2024-12-24.
What interventions are being tested in trial NCT06096181?
The interventions under investigation include: Remifentanil TIVA (DRUG), Dexmedetomidine TIVA (DRUG), Propofol TIVA (DRUG).
Who is sponsoring clinical trial NCT06096181?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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