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

NCT06096181 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: STUDY00002614
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1

  Measure the median total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.

  Post Op Day# 0 and 1

• Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1

  Measure the mean total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.

  Post Op Day# 0 and 1

Secondary Outcomes (3)

• Mean VAS Pain Score on POD# 0 and 1

  Post Op Day# 0 and 1

• Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins)

  Intraoperative (day of surgery)

• Time From Skin Closure to Extubation

  Intraoperative (day of surgery)

Study Arms (2)

Propofol + Remifentanil

ACTIVE COMPARATOR

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.

Drug: Remifentanil TIVA; Drug: Propofol TIVA

Propofol + Dexmedetomidine

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine TIVA; Drug: Propofol TIVA

Interventions

Remifentanil TIVA DRUG

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

Also known as: Ultiva TIVA

Propofol + Remifentanil

Dexmedetomidine TIVA DRUG

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

Also known as: Precedex TIVA

Propofol + Dexmedetomidine

Propofol TIVA DRUG

Propofol is an anesthetic drug that causes sleep during surgery.

Also known as: Diprivan TIVA

Propofol + Dexmedetomidine; Propofol + Remifentanil

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-18 years old
• American Society of Anesthesiology Physical Status Classification (ASA Class) 1 and 2
• Have diagnosis of Adolescent Idiopathic Scoliosis
• Undergoing Posterior Spinal Fusion with instrumentation for scoliosis correction
• Matched on age, sex, and the number of vertebral levels fused

You may not qualify if:

• Neuromuscular scoliosis
• Allergy to any of the multi-modal analgesia regimen drugs
• Use of serotonergic drugs, monoamine oxidase inhibitors (MAOI), mixed agonist/antagonist opioid analgesics

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

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MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study terminated early. Motor evoked potentials (MEP) is a monitor of spinal cord integrity, used to detect and prevent new neurological deficits in the context of spine surgery. Following anecdotally observed effects of some anesthetics interfering with MEP in patients undergoing scoliosis surgery, the surgeon involved in the study decided to pause enrollment and ultimately terminate the study early out of caution for patients.

Results Point of Contact

• Title: Glenn Tan, MD
• Organization: Cedars-Sinai Medical Center

Glenn.Tan@cshs.org

310-423-5841

Study Officials

• Glenn Tan, M.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The following persons are masked: 1. Participant and parents 2. Pediatric Intensive Care Unit (PICU) staff taking care of patient postoperatively 3. Surgeon
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Anesthesia

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: December 20, 2023
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)