Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 8 for:    CARISOPRODOL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02521831
Recruitment Status : Withdrawn
First Posted : August 13, 2015
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Emmett Whitaker, M.D., Nationwide Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Drug: Spinal Anesthesia (bupivacaine) Drug: General Anesthesia (isoflurane) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Layout table for additonal information
Responsible Party: Emmett Whitaker, M.D., Clinical Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02521831     History of Changes
Other Study ID Numbers: IRB15-00125
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Emmett Whitaker, M.D., Nationwide Children's Hospital:
Circumcision

Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia, Inguinal
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Anesthetics
Bupivacaine
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General