← Back to Search

Sedative

Anesthesia Combinations for Scoliosis Surgery

Phase 2

Recruiting

Led By Glenn Tan, M.D.

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiology Physical Status Classification (ASA Class) 1 and 2

Age 12-18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative (day of surgery)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare two different combinations of anesthesia medications used during surgery for Adolescent Idiopathic Scoliosis. One combination includes Propofol and Remifentanil, while the other includes

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include increased sensitivity to pain after surgery when using remifentanil (opioid-induced hyperalgesia) and the typical risks associated with general anesthesia such as nausea, drowsiness, or respiratory issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am in good health or have mild systemic disease.

Select...

I am between 12 and 18 years old.

Select...

I have been diagnosed with Adolescent Idiopathic Scoliosis.

Select...

I am having surgery with metal rods for my scoliosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post op day# 0 and 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post op day# 0 and 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and post op day# 0 and 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total opioid consumption (IV and PO in MME) on POD# 0 and 1

Secondary study objectives

Average VAS Pain score on POD# 0 and 1

Time from skin closure to Extubation

Time from skin closure to participant being able to move their feet on command (mins)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Propofol + RemifentanilActive Control2 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 + DexmedetomidineActive Control2 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.

0 / 4Eligibility criteria met