Neuroinflammatory and Neurocognitive Effects of Spinal vs. Inhalational Anesthesia for Elective Surgery in Infants
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|ClinicalTrials.gov Identifier: NCT02521831|
Recruitment Status : Withdrawn
First Posted : August 13, 2015
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inguinal Hernia||Drug: Spinal Anesthesia (bupivacaine) Drug: General Anesthesia (isoflurane)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Neuroinflammatory and Neurocognitive Effects of Spinal vs. Inhalational Anesthesia for Elective Surgery in Infants: A Randomized, Controlled, Double-Blinded Study|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Active Comparator: General Anesthesia
Inhalational anesthesia with Isoflurane 1-2% in 50%/50% oxygen/air mixture.
This arm will receive the General Anesthesia (isoflurane) intervention exclusively.
Drug: General Anesthesia (isoflurane)
Isoflurane is a fluorinated ether with general anesthetic and muscle relaxant effects. Brand names include Forane and Terrell.
Other Name: Standard Inhalational Anesthesia
Active Comparator: 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.
Drug: Spinal Anesthesia (bupivacaine)
Bupivacaine is an amide-type, long-acting local anesthetic. Brand names include Exparel, Marcaine, and Sensorcaine.
Other Name: Regional Anesthesia
- Change in proinflammatory miRNAs [ Time Frame: Blood will be drawn before surgical incision, at the conclusion of the surgery (typically ~1 hour after incision), and at arrival to the PACU (typically 10-30 minutes after end of surgery) ]
Blood samples will be analyzed for a composite measure of systemic inflammation caused by the anesthetic agent. MicroRNA (miRNA) expression will be compared between the time points for each patient and between arms.
Total RNA will be extracted from whole blood using a commercially available kit. RNA will then be assayed for transcriptome analysis using microarray technology.
Serum cytokines will be analyzed using Enzyme-Linked Immunosorbent Assay (ELISA) for Tumor Necrosis Factor alpha (TNF-α), Interleukin one beta (IL-1β),Monocyte Chemoattractant Protein one (MCP-1), Prostaglandin E2 (PGE2), Nuclear Factor kappa-light-chain-enhancer of activated B cells (NF-ĸB), transcription factor p65, and S100 calcium-binding protein B (S100B). miR-155, miR-146a, miR-146b, and miR-142-3p will be quantified using quantified polymerase chain reaction (qPCR).
- Change in systemic inflammation [ Time Frame: Blood will be drawn before surgical incision, at the conclusion of the surgery (typically ~1 hour after incision), and at arrival to the PACU (typically 10-30 minutes after end of surgery) ]Inflammatory biomarkers in the serum will be compared between time points and between arms.