Anesthesia Combinations for Scoliosis Surgery

Overseen By Glenn Tan

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Serotonergic drugs, MAOIs

Disqualifiers: Neuromuscular scoliosis, drug allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best anesthesia combination for children undergoing scoliosis surgery. It compares two drug pairs: Propofol with Remifentanil (an opioid) and Propofol with Dexmedetomidine (also known as Precedex, a sedative). The goal is to determine which combination results in less pain and reduces the need for opioids after surgery. Children with Adolescent Idiopathic Scoliosis scheduled for specific spine surgery may be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in pediatric anesthesia care.

Will I have to stop taking my current medications?

The trial requires that you do not use serotonergic drugs, monoamine oxidase inhibitors (MAOI), or mixed agonist/antagonist opioid analgesics. If you are taking any of these, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both anesthetic combinations, Propofol + Remifentanil and Propofol + Dexmedetomidine, are commonly and safely used in surgeries, including those for scoliosis.

The Propofol + Remifentanil combination often serves as a standard choice for major spine surgeries because it provides effective pain relief during the operation. However, some studies suggest that remifentanil might increase sensitivity to pain afterward, potentially requiring more pain medication post-surgery. This effect is known as opioid-induced hyperalgesia.

Dexmedetomidine, while not FDA-approved for children, sees widespread use in pediatric surgeries. Research indicates that it can reduce the need for higher doses of other anesthetics, potentially limiting side effects. When combined with Propofol, Dexmedetomidine offers safe and effective sedation without causing heart or breathing problems.

Overall, both combinations have a history of safe use in surgeries. Prospective trial participants should consult their healthcare provider to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these anesthesia combinations for scoliosis surgery because they offer new ways to manage pain and sedation during complex procedures. Unlike the standard of care, which often relies on opioids and inhaled anesthetics, these combinations use Propofol with either Remifentanil or Dexmedetomidine. Dexmedetomidine is particularly noteworthy for its ability to provide sedation without respiratory depression, a common issue with traditional opioids. Meanwhile, Remifentanil offers precise, short-term pain control due to its ultra-short-acting nature. These innovative options could potentially improve patient safety and recovery times during scoliosis surgery.

What evidence suggests that these anesthesia combinations could be effective for scoliosis surgery?

This trial will compare two anesthesia combinations for scoliosis surgery. Research has shown that Propofol and Remifentanil are commonly used together in scoliosis surgery because they maintain patient sleep without affecting nerve monitoring. However, Remifentanil can sometimes increase post-surgery pain sensitivity. Alternatively, the combination of Propofol and Dexmedetomidine, also under study in this trial, provides steady anesthesia with fewer side effects. Although Dexmedetomidine lacks FDA approval for children, it is widely used and may reduce post-surgery pain without increasing sensitivity. This combination is popular in adult spine surgeries and is being studied for its potential benefits in children undergoing similar operations. ^{1 2 5 6 7}

Who Is on the Research Team?

Glenn Tan, M.D.

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-18 with Adolescent Idiopathic Scoliosis, classified as ASA Class 1 or 2, who are undergoing posterior spinal fusion surgery. They must be matched by age, sex, and number of vertebral levels fused.

Inclusion Criteria

I am in good health or have mild systemic disease.

My age, sex, and spine surgery details match the study requirements.

I have been diagnosed with Adolescent Idiopathic Scoliosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo posterior spinal fusion surgery with either Propofol + Remifentanil or Propofol + Dexmedetomidine as their total intravenous anesthesia

1 day

1 visit (in-person)

Postoperative Monitoring

Participants' opioid consumption and pain scores are measured on postoperative days 0 and 1

2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Remifentanil

Trial Overview The study compares two anesthesia combinations during spine surgery: Propofol + Remifentanil vs. Propofol + Dexmedetomidine. It aims to determine which combination leads to less postoperative pain and opioid use while allowing faster recovery from anesthesia.

How Is the Trial Designed?

Group I: Propofol + Remifentanil Active Control 2 Interventions

Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) \< 55-60 to ensure patient is asleep.

Group II: Propofol + Dexmedetomidine Active Control 2 Interventions

Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) \< 55-60 to ensure patient is asleep.

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a study of 89 adolescent patients undergoing surgery for idiopathic scoliosis, no significant relationship was found between the dose of intraoperative remifentanil and the amount of opioids consumed in the 72 hours following surgery.

The findings suggest that using remifentanil as part of total intravenous anesthesia does not increase postoperative opioid consumption, indicating that it may not contribute to acute opioid tolerance or hyperalgesia in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Intraoperative Remifentanil Dosage and Postoperative Opioid Consumption in Adolescent Idiopathic Spine Surgery: A Retrospective Cohort Study. Lo, C., Schwindt, S., Sharma, R., et al.[2023]

A survey of 27 institutions revealed that common anaesthetic practices for paediatric scoliosis surgery include the use of inhaled volatile agents (80%) and intravenous remifentanil (88%), indicating a trend towards modern, effective anaesthetic techniques.

Despite the variety in practices, the use of blood-sparing techniques like cell-saver (81%) and controlled hypotension (77%) was prevalent, highlighting a focus on minimizing blood loss during surgery, although 54 adverse neurological or cardiac events were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-centre multi-national survey of anaesthetists regarding the range of anaesthetic and surgical practices for paediatric scoliosis surgery. Palmer, GM., Pirakalathanan, P., Skinner, AV.[2019]

In a study of 60 ASA III patients undergoing spinal orthopedic scoliosis correction surgery, dexmedetomidine at doses of 0.2 to 0.3 μg/(kg·h) resulted in shorter wake-up times and fewer hemodynamic fluctuations compared to a higher dose of 0.4 μg/(kg·h).

Group B (0.3 μg/(kg·h)) showed significantly higher mean arterial pressure just before and at the moment of wake-up compared to Group A (0.2 μg/(kg·h)), indicating better hemodynamic stability with this dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine dosage in critically ill patients undergoing intraoperative wake-up test: A randomized controlled trial. Yang, T., Mudabbar, MS., Chen, T., et al.[2022]

In a study of 120 children undergoing scoliosis surgery, those who received remifentanil were extubated shortly after surgery, while those on morphine took significantly longer (average of 5.4 hours).

Remifentanil not only led to shorter surgery times (5.6 hours vs. 7.14 hours for morphine) but also resulted in fewer patients needing intensive care, all without increasing the risk of major complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remifentanil use in pediatric scoliosis surgery-an effective alternative to morphine (a retrospective study). Abu-Kishk, I., Hod-Feins, R., Anekstein, Y., et al.[2021]

Dexmedetomidine and ketamine were effectively used as the main anesthetic agents for a 15-year-old girl undergoing scoliosis repair surgery, providing adequate anesthesia while allowing for intraoperative neurophysiological monitoring.

This combination resulted in minimal need for vasoactive support during the 12-hour procedure, demonstrating a potentially safer alternative to traditional propofol-based anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of dexmedetomidine and ketamine infusions during scoliosis repair surgery with somatosensory and motor-evoked potential monitoring: a case report. Penney, R.[2013]

Dexmedetomidine, when used during scoliosis surgery in pediatric patients, may lead to loss of motor evoked potentials (MEP), especially at higher doses, indicating a potential risk for neurophysiological monitoring during surgery.

The review highlighted substantial variability in study quality, with lower bias studies suggesting a negative impact of dexmedetomidine on MEP, while higher bias studies reported no significant effects, emphasizing the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of dexmedetomidine on intraoperative neurophysiologic monitoring modalities during corrective scoliosis surgery in pediatric patients: A systematic review. Abdelaal Ahmed Mahmoud Metwally Alkhatip, A., Mills, KE., Hogue, O., et al.[2023]

In a case study of a 16-year-old girl undergoing scoliosis surgery, the use of dexmedetomidine in combination with total intravenous anesthesia provided effective sedation and analgesia during the critical wake-up test, allowing for safe assessment of lower limb movement.

The patient successfully regained spontaneous ventilation and was able to move her lower limbs upon command 14 minutes after the withdrawal of propofol and remifentanil, demonstrating the efficacy of dexmedetomidine in maintaining sedation while ensuring patient safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dexmedetomidine as adjuvant drug for wake-up test during scoliosis correction surgery: case report.]. Bagatini, A., Volquind, D., Rosso, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8913085/

Dexmedetomidine dosage in critically ill patients undergoing ... The aim of this study was to find the optimum dosage of dexmedetomidine in Spinal Orthopedic Scoliosis Correction Surgery when used in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06096181

Study Details | NCT06096181 | Propofol + Remifentanil vs. ... The purpose of this study is to compare two combinations of total intravenous anesthetic medications in children with Adolescent Idiopathic Scoliosis having ...

3. scholarlycommons.henryford.com scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1964&context=cardiology_articles

Outcomes of dexmedetomidine versus propofol sedation in ... dexmedetomidine slightly reduces the duration of mechanical ventilation and risk of delirium in cardiac surgical patients but increases the risk ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5335826/

Combined use of dexmedetomidine and propofol in ... The combined use of propofol and dexmedetomidine provided cardiovascular stability with decreased adverse effects.

5. trials.arthritis.org trials.arthritis.org/trials/NCT06096181

Propofol + Remifentanil vs. Propofol + Dexmedetomidine in ... An alternative TIVA that is very commonly used for adult spine surgery is propofol + dexmedetomidine (DEX). DEX is a highly selective alpha2-adrenergic receptor ...

6. withpower.com withpower.com/trial/phase-2-scoliosis-11-2023-82b19

Anesthesia Combinations for Scoliosis Surgery Dexmedetomidine helps reduce the need for higher doses of other anesthetics, potentially minimizing their side effects, while Remifentanil provides short-acting ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9885827/

To Compare the Safety and Efficacy of Conscious Sedation ... Dexmedetomidine and propofol provide adequate sedation without any cardiorespiratory compromise when used for conscious sedation for minimally invasive spine ...