Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery

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 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

Conditions

• Adolescent Idiopathic Scoliosis
• Multimodal Analgesia
• Opioid Induced Hyperalgesia
• Remifentanil
• Dexmedetomidine
• Posterior Spinal Fusion

Interventions

DRUG

Remifentanil TIVA

Remifentanil is more commonly used in the TIVA combination for pediatric patients having this surgery.

DRUG

Dexmedetomidine TIVA

Dexmedetomidine is less commonly used in the TIVA combination for pediatric patients having this surgery.

DRUG

Propofol TIVA

Propofol is an anesthetic drug that causes sleep during surgery.

Sponsors & Collaborators

• Cedars-Sinai Medical Center

  lead OTHER

Principal Investigators

• Glenn Tan, M.D. · Cedars-Sinai Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-20

Primary Completion

2024-12-24

Completion

2024-12-24

FDA Drug

Yes

Countries

• United States

Study Locations