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

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06096181
Collaborator
(none)
120
Enrollment
2
Arms
54
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Remifentanil TIVA
  • Drug: Dexmedetomidine TIVA
  • Drug: Propofol TIVA
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Masking Description:
The following persons are masked: Participant and parents Pediatric Intensive Care Unit (PICU) staff taking care of patient postoperatively Surgeon
Primary Purpose:
Prevention
Official Title:
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
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

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: Dexmedetomidine TIVA
    Dexmedetomidine is less commonly used in the TIVA combination for pediatric patients having this surgery.
    Other Names:
  • Precedex TIVA

    • Drug: Propofol TIVA
    Propofol is an anesthetic drug that causes sleep during surgery.
    Other Names:
  • Diprivan TIVA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total opioid consumption (IV and PO in MME) on POD# 0 and 1 [Post Op Day# 0 and 1]

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

    Secondary Outcome Measures

    1. Average VAS Pain score on POD# 0 and 1 [Post Op Day# 0 and 1]

      Measure the average 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.

    2. Time from skin closure to participant being able to move their feet on command (mins) [Intraoperative (day of surgery)]

      Measure the time (mins) from completion of surgical skin closure to the participant being able to move their feet to command

    3. Time from skin closure to Extubation [Intraoperative (day of surgery)]

      Measure the time (mins) from completion of surgical skin closure to extubation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Glenn Tan, M.D., Director of Pediatric Anesthesia, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT06096181
    Other Study ID Numbers:
    • STUDY00002614
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Scoliosis
    Hyperalgesia
    Dexmedetomidine
    Remifentanil
    Propofol

    Study Results

    No Results Posted as of Oct 23, 2023