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Spreading Depolarization and Ketamine Suppression

NCT02501941 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-01-11

No results posted yet for this study

Summary

Hypothesis: Cortical spreading depolarizations are inhibited by the NMDA receptor antagonist Ketamine Aim 1: To demonstrate, in a group of patients with acute severe brain injury requiring surgery including traumatic brain injury and aneurysmal subarachnoid hemorrhage, whether use of continuous infusion of ketamine decreases frequency of occurrence of cortical spreading depolarizations.

Conditions

  • Cortical Spreading Depolarization
  • Cortical Spreading Depression
  • Subarachoid Hemorrhage
  • Traumatic Brain Injury

Interventions

DRUG

ketamine

Ketamine will be used as a sedative alternative to other more conventional sedatives (such as propofol, versed, or dexmedetomidine) in 6 hour blocks of time. Ketamine will be titrated at the bedside based on clinically desired Riker Sedation-Agitation Scale target. Both groups will receive the drug in this multiple crossover design. The only difference between groups is which sedation regimen is started first to minimize any bias related to differences in physiology in the early post-operative phase.

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Andrew P Carlson, MD · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-01-01
Completion
2017-05-01

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02501941 on ClinicalTrials.gov