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This is a clinical trial that intend to determine the effects of S-ketamine on event-related potentials associated with semantic affective pain-processing
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group S-Ketamine | Experimental | 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. |
|
| Group Placebo | Placebo Comparator | A previously prepared identical solution containing only normal saline will be infused at the same infusion rates of group ketamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Word ratings related to the semantic valence | After viewing each word, volunteers were asked to classify them according to the semantic valence in the following categories: "positive," "negative" or "neutral." | up to 60 min |
| Response times (behavioural oddball data) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective euphoria rating | Euphoria will be rated using an analogue visual scale ranging of 0 to 10. | up to 60 min |
| Subjective sedation rating | Sedation will be rated using an analogue visual scale ranging of 0 (completely awake) to 100 (sleeping). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolnei Caumo, MD, PhD | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31611759 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2019 | |
| Reset | May 13, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2019 | May 13, 2019 |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Administered in an identical way than ketamine. |
|
Response times to word classification in oddball task |
| up to 60 min |
| up to 60 min |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |