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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-02

Study Completion Date

2017-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Acute Pain Chronic Pain, Widespread Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

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

Group Placebo

A previously prepared identical solution containing only normal saline will be infused at the same infusion rates of group ketamine.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered in an identical way than ketamine.

Interventions

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Ketamine

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

Intervention Type DRUG

Placebo

Administered in an identical way than ketamine.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes