Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
This is a clinical trial that intend to determine the effects of S-ketamine on event-related potentials associated with semantic affective pain-processing
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2017
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedFirst Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedApril 16, 2019
January 1, 2018
11 months
April 12, 2019
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUC of the grand averaged mean differences between ERPs elicited by target and non-target words
EEG will be recorded during all task time. The main outcome will be the area under de curve (AUC) of the grand averaged mean differences between event-related potencials (ERPs) elicited by target and non-target words at 100-200, 300-500 and 800-900 ms after stimulus presentation for parietal electrophysiological signal (Pz). The ERPs represent the averaged voltage of several trials.
up to 60 min
Secondary Outcomes (2)
Word ratings related to the semantic valence
up to 60 min
Response times (behavioural oddball data)
up to 60 min
Other Outcomes (2)
Subjective euphoria rating
up to 60 min
Subjective sedation rating
up to 60 min
Study Arms (2)
Group S-Ketamine
EXPERIMENTALS-Ketamine will be diluted in normal saline and administrated in a target controlled infusion using an infusion pump to obtain a plasma target of 60 ng/ml according to Domino's model. Infusion will start during the interval between the 3rd and 4th blocks of the task.
Group Placebo
PLACEBO COMPARATORA previously prepared identical solution containing only normal saline will be infused at the same infusion rates of group ketamine.
Interventions
Eligibility Criteria
You may qualify if:
- male healthy subjects with higher education level
You may not qualify if:
- do not understand Portuguese language
- obese patients (BMI \> 27 kg/m2)
- use of NSAID, steroids, analgesics, anticonvulsant drugs, as well as alpha and beta-blockers
- score ≥ 13 on Beck II Questionnaire
- sleep deprivation in the night before evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Schwertner A, Zortea M, Torres FV, Ramalho L, Alves CFDS, Lannig G, Torres ILS, Fregni F, Gauer G, Caumo W. S-Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain: A Placebo- Controlled Study in Healthy Male Individuals. Front Neurosci. 2019 Sep 13;13:959. doi: 10.3389/fnins.2019.00959. eCollection 2019.
PMID: 31611759DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolnei Caumo, MD, PhD
Hospital de Clínicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 16, 2019
Study Start
January 2, 2017
Primary Completion
November 30, 2017
Study Completion
November 30, 2017
Last Updated
April 16, 2019
Record last verified: 2018-01