Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain
|ClinicalTrials.gov Identifier: NCT03915938|
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Chronic Pain, Widespread Schizophrenia||Drug: Ketamine Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain: a Placebo-controlled Study in Healthy Male Subjects|
|Actual Study Start Date :||January 2, 2017|
|Actual Primary Completion Date :||November 30, 2017|
|Actual Study Completion Date :||November 30, 2017|
Experimental: Group S-Ketamine
S-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.
S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml
Placebo Comparator: Group Placebo
A previously prepared identical solution containing only normal saline will be infused at the same infusion rates of group ketamine.
Administered in an identical way than ketamine.
- AUC of the grand averaged mean differences between ERPs elicited by target and non-target words [ Time Frame: up to 60 min ]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.
- Word ratings related to the semantic valence [ Time Frame: up to 60 min ]After viewing each word, volunteers were asked to classify them according to the semantic valence in the following categories: "positive," "negative" or "neutral."
- Response times (behavioural oddball data) [ Time Frame: up to 60 min ]Response times to word classification in oddball task
- Subjective euphoria rating [ Time Frame: up to 60 min ]Euphoria will be rated using an analogue visual scale ranging of 0 to 10.
- Subjective sedation rating [ Time Frame: up to 60 min ]Sedation will be rated using an analogue visual scale ranging of 0 (completely awake) to 100 (sleeping).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915938
|Principal Investigator:||Wolnei Caumo, MD, PhD||Hospital de Clínicas de Porto Alegre|