Anesthesia Combinations for Scoliosis Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Glenn Tan, M.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Serotonergic drugs, MAOIs

Disqualifiers: Neuromuscular scoliosis, drug allergies, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 the time it takes for participants to be extubated when surgery is done. By comparing these measurements, the investigators hope to find out if there is any significant difference between the two TIVAs in terms of postop opioid requirements, pain scores, and time to wake up from anesthesia. The investigators hope that our study gives us more knowledge on how to better treat postoperative pain in children who have spine surgery to correct their

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 the combination of dexmedetomidine and remifentanil safe for scoliosis surgery?

Dexmedetomidine and remifentanil are used in scoliosis surgery to help with sedation and pain management. While remifentanil is effective, it may lead to increased pain and opioid use after surgery. Dexmedetomidine is used to maintain stability during surgery, but specific safety data for these drugs in scoliosis surgery is limited. ^{1 2 3 4 5}

How is the drug combination of Dexmedetomidine and Remifentanil unique for scoliosis surgery?

This drug combination is unique because it allows for sedation and pain relief while maintaining ventilatory stability during the wake-up test, a critical part of scoliosis surgery to check for nerve function. Dexmedetomidine helps reduce the need for higher doses of other anesthetics, potentially minimizing their side effects, while Remifentanil provides short-acting pain control. ^{1 2 4 6 7}

Research Team

Glenn Tan, M.D.

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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 am between 12 and 18 years old.

Trial Timeline

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

Treatment Details

Interventions

• Dexmedetomidine (Sedative)
• Remifentanil (Opioid)

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.

Participant Groups

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 Canada, Japan for the following indications:

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+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

Findings from Research

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Dexmedetomidine as adjuvant drug for wake-up test during scoliosis correction surgery: case report.]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Association Between Intraoperative Remifentanil Dosage and Postoperative Opioid Consumption in Adolescent Idiopathic Spine Surgery: A Retrospective Cohort Study. [2023]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine dosage in critically ill patients undergoing intraoperative wake-up test: A randomized controlled trial. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Remifentanil use in pediatric scoliosis surgery-an effective alternative to morphine (a retrospective study). [2021]

6. United States 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. [2013]

7. France pubmed.ncbi.nlm.nih.gov

The effects of dexmedetomidine on intraoperative neurophysiologic monitoring modalities during corrective scoliosis surgery in pediatric patients: A systematic review. [2023]