Neuroinflammatory and Neurocognitive Effects of Spinal vs. Inhalational Anesthesia for Elective Surgery in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-12-31

Brief Summary

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Significant concern regarding the safety of general anesthesia in children has arisen due to myriad animal studies suggesting neurotoxicity of commonly used anesthetic agents. Inflammation of the central nervous system after anesthesia may have a significant role in the pathogenesis of anesthetic-induced neural injury. To evaluate this hypothesis, the investigators propose to randomize healthy infants undergoing elective surgery to one of two anesthetics: 1) spinal anesthesia only; or 2) general inhalational anesthesia with isoflurane, laryngeal mask airway (LMA) or endotracheal tube (ETT), and single-shot caudal block. Primary endpoint will be serum inflammatory biomarkers and transcriptome analysis and secondary endpoint will be neurocognitive outcome at 6 months and 1 year.

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Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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General Anesthesia

Inhalational anesthesia with Isoflurane 1-2% in 50%/50% oxygen/air mixture.

This arm will receive the General Anesthesia (isoflurane) intervention exclusively.

Group Type ACTIVE_COMPARATOR

General Anesthesia (isoflurane)

Intervention Type DRUG

Isoflurane is a fluorinated ether with general anesthetic and muscle relaxant effects. Brand names include Forane and Terrell.

Spinal Anesthesia

These infants will not receive any anesthetic gas prior to the spinal. These infants will be conscious for this procedure.

Spinal will be administered, containing 0.25% isobaric bupivacaine, 1 mg/kg (maximum 5mg), Clonidine, 1 µg/kg, and Epinephrine, 1:200,000.

This arm will receive the Spinal Anesthesia (bupivacaine) intervention exclusively.

Group Type ACTIVE_COMPARATOR

Spinal Anesthesia (bupivacaine)

Intervention Type DRUG

Bupivacaine is an amide-type, long-acting local anesthetic. Brand names include Exparel, Marcaine, and Sensorcaine.

Interventions

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Spinal Anesthesia (bupivacaine)

Bupivacaine is an amide-type, long-acting local anesthetic. Brand names include Exparel, Marcaine, and Sensorcaine.

Intervention Type DRUG

General Anesthesia (isoflurane)

Isoflurane is a fluorinated ether with general anesthetic and muscle relaxant effects. Brand names include Forane and Terrell.

Intervention Type DRUG

Other Intervention Names

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Regional Anesthesia Standard Inhalational Anesthesia

Eligibility Criteria

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Inclusion Criteria

1. Otherwise healthy child aged 0-less than 13 months undergoing elective (non-emergent) general, urologic, orthopedic, and plastic surgery
2. Parent/guardian must provide written informed consent in accordance with human investigation committee guidelines
3. Participants must be American Society of Anesthesiologist (ASA) physical status ≤ 2

Exclusion Criteria

1. Any active bacterial or viral infection within the last 14 days
2. Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or corticosteroid medications, or any other drug known to suppress or induce inflammation
3. Anticoagulant administration in the last 48 hours
4. Patients that have an American Society of Anesthesiologists physical status \>2
5. Infants born more than 4 weeks premature

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No