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Completed

NCT Number: NCT03915938

Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml

Placebo

Drug

Administered in an identical way than ketamine.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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."

  2. Response times (behavioural oddball data)

    Time frame: up to 60 min

    Response times to word classification in oddball task

Other outcomes

  1. Subjective euphoria rating

    Time frame: up to 60 min

    Euphoria will be rated using an analogue visual scale ranging of 0 to 10.

  2. 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).

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain: a Placebo-controlled Study in Healthy Male Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 16, 2019
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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