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

October 22, 2025 updated by: Glenn Tan, M.D., Cedars-Sinai Medical Center

A Prospective Study Comparing Total Intravenous Anesthesia With Propofol and Remifentanil vs. Propofol and Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion and Instrumentation

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients with Adolescent Idiopathic Scoliosis (AIS) 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. Total intravenous anesthesia (TIVA) is the usual anesthetic technique of choice.

The purpose of this study is to compare two combinations of TIVA medications in children AIS having posterior spinal fusion surgery.

The most common TIVA for this surgery at our institution is Propofol + Remifentanil. Remifentanil is a popular choice because of its rapid onset, extremely short context-sensitive half-life, potency, and its rapid recovery from drug effect. However, an important concern with intraoperative remifentanil infusion is the possible development of acute opioid-induced hyperalgesia (OIH). In adults, OIH is a well-documented feature linked to intraoperative remifentanil administration, manifesting as increased postoperative analgesic requirement and paradoxical increase in sensitivity to painful stimuli. In pediatric patients, the phenomenon is not as well characterized.

An alternative TIVA that is very commonly used for adult spine surgery is propofol + dexmedetomidine (DEX). DEX is a highly selective alpha2-adrenergic receptor agonist with sedative, analgesic, and sympatholytic properties.

Despite the lack of FDA approval for pediatric use, DEX is widely used off-label in pediatric patients in the US and worldwide and has previously been shown to be safe and efficacious for various clinical indications including procedural sedation, craniotomy-awake-surgery, cardiac surgery, and posterior spinal fusion for scoliosis. DEX is currently used safely in pediatric and adult spine patients in our institution. The most common adverse effect is intraoperative bradycardia.

Participants will be randomized to receive one of the two TIVAs to see if one or the other results in lower opioid consumption, and lower Visual Analog Scale (VAS) pain scores in the post-operative period (POD# 0 and 1). The investigators hypothesize that the use of DEX will avoid OIH and this will lead to less opioid consumption in the postoperative period, and superior postoperative pain control. The investigators also hope to show that the use of DEX will not significantly prolong time to moving feet to command and extubation at conclusion of surgery.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol + Remifentanil
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
Remifentanil is more commonly used in the TIVA combination for pediatric patients having this surgery.
Other Names:
  • Ultiva TIVA
Drug: Propofol TIVA
Propofol is an anesthetic drug that causes sleep during surgery.
Other Names:
  • Diprivan TIVA
Active Comparator: Propofol + Dexmedetomidine
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: Propofol TIVA
Propofol is an anesthetic drug that causes sleep during surgery.
Other Names:
  • Diprivan TIVA
Drug: Dexmedetomidine TIVA
Dexmedetomidine is less commonly used in the TIVA combination for pediatric patients having this surgery.
Other Names:
  • Precedex TIVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
Time Frame: Post Op Day# 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
Time Frame: Post Op Day# 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean VAS Pain Score on POD# 0 and 1
Time Frame: Post Op Day# 0 and 1
Measure the mean pain score of the participant on a visual analog pain scale. The VAS has two end points representing 0 ("no pain") and 10 ("worst pain ever"). It is reported at our institution as a number between 0 and 10.
Post Op Day# 0 and 1
Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins)
Time Frame: Intraoperative (day of surgery)
Measure the median time (mins) from completion of surgical skin closure to the participant being able to move their feet to command.
Intraoperative (day of surgery)
Time From Skin Closure to Extubation
Time Frame: Intraoperative (day of surgery)
Measure the median time (mins) from completion of surgical skin closure to extubation.
Intraoperative (day of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Glenn Tan, M.D., Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Actual)

December 24, 2024

Study Completion (Actual)

December 24, 2024

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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