ketamine
DrugS-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml
NCT Number: NCT03915938
This is a clinical trial that intend to determine the effects of S-ketamine on event-related potentials associated with semantic affective pain-processing
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Notify Me18 year–40 year
Male
Interventional
Phase 2 / Phase 3
Ketamine is a unique anesthetic with neural effects that are distinct from more commonly-used γ-aminobutyric acid agonists. Evidence suggest that analgesic effect of ketamine is primarily related to the affective than the sensorial aspects of pain interpretation. The investigators investigated whether ketamine, a noncompetitive NMDA antagonist, would modify the perceived emotional valence of pain-related words when compared to non-pain-related ones in healthy volunteers. Using a single session double-blind parallel placebo-controlled design, 24 healthy volunteers were randomized to receive intravenous S-ketamine (n=12) or placebo (n=12). During infusion (plasmatic target of 60 ng/ml), the effects of ketamine were recorded using EEG and oddball behavioral data was monitored. Evoked potentials (N200 and P300 components) were recorded during performance of a semantic written word oddball task containing pain-related (targets) and non-pain-related words (standards). Expected results: The findings of this study can help in the understanding of neurophysiologic mechanisms involved in ketamine's effects both in psychiatric diseases as in the treatment of postoperative acute and chronic pain.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml
Administered in an identical way than ketamine.
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.
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."
Time frame: up to 60 min
Response times to word classification in oddball task
Time frame: up to 60 min
Euphoria will be rated using an analogue visual scale ranging of 0 to 10.
Time frame: up to 60 min
Sedation will be rated using an analogue visual scale ranging of 0 (completely awake) to 100 (sleeping).
Hospital de Clinicas de Porto Alegre
Other
Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain: a Placebo-controlled Study in Healthy Male Subjects
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