Trials / Withdrawn
WithdrawnNCT02521831
Neuroinflammatory and Neurocognitive Effects of Spinal vs. Inhalational Anesthesia for Elective Surgery in Infants
Neuroinflammatory and Neurocognitive Effects of Spinal vs. Inhalational Anesthesia for Elective Surgery in Infants: A Randomized, Controlled, Double-Blinded Study
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Emmett Whitaker, M.D. · Academic / Other
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Spinal Anesthesia (bupivacaine) | Bupivacaine is an amide-type, long-acting local anesthetic. Brand names include Exparel, Marcaine, and Sensorcaine. |
| DRUG | General Anesthesia (isoflurane) | Isoflurane is a fluorinated ether with general anesthetic and muscle relaxant effects. Brand names include Forane and Terrell. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-12-31
- Completion
- 2017-12-31
- First posted
- 2015-08-13
- Last updated
- 2018-01-25
Source: ClinicalTrials.gov record NCT02521831. Inclusion in this directory is not an endorsement.