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

Emmett Whitaker, M.D.

Status and phase: Withdrawn; Phase 3

Conditions: Inguinal Hernia

Treatments: Drug: General Anesthesia (isoflurane); Drug: Spinal Anesthesia (bupivacaine)

Study type: Interventional

Funder types: Other

Identifiers

NCT02521831

IRB15-00125

Details and patient eligibility

About

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.

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

General Anesthesia

Active Comparator group

Description:

Inhalational anesthesia with Isoflurane 1-2% in 50%/50% oxygen/air mixture. This arm will receive the General Anesthesia (isoflurane) intervention exclusively.

Treatment:

Drug: General Anesthesia (isoflurane)

Spinal Anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Spinal Anesthesia (bupivacaine)