CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
ketaminedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02501941
NCT02501941Phase 1Completed
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Spreading Depolarization and Ketamine Suppression

University of New Mexico·interventional·Posted Jul 17, 2015·Updated Jan 11, 2024

In Brief

A Phase 1 clinical trial evaluating ketamine for Cortical Spreading Depolarization and 3 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCortical Spreading Depolarization, Cortical Spreading Depression, Subarachoid Hemorrhage, Traumatic Brain Injury
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 17, 2015
Enrollment StartJul 1, 2015
Primary CompletionJan 1, 2017
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.0 years ago

Interventions

ketaminedrug

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.