Clinical trial NCT03915938: Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Pain
Chronic Pain, Widespread
Schizophrenia
Keywords: Ketamine
ERP
Oddball
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* male healthy subjects with higher education level

Exclusion Criteria:

* 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

Primary outcomes:
measure: AUC of the grand averaged mean differences between ERPs elicited by target and non-target words
timeFrame: up to 60 min
Secondary outcomes:
measure: Word ratings related to the semantic valence
timeFrame: up to 60 min
measure: Response times (behavioural oddball data)
timeFrame: up to 60 min
Other outcomes:
measure: Subjective euphoria rating
timeFrame: up to 60 min
measure: Subjective sedation rating
timeFrame: up to 60 min
Locations:
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Wolnei Caumo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.