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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915938
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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

Condition or disease Intervention/treatment Phase
Acute Pain Chronic Pain, Widespread Schizophrenia Drug: Ketamine Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: 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.
Drug: Ketamine
S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml

Placebo Comparator: Group Placebo
A previously prepared identical solution containing only normal saline will be infused at the same infusion rates of group ketamine.
Drug: Placebo
Administered in an identical way than ketamine.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915938


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Wolnei Caumo, MD, PhD Hospital de Clínicas de Porto Alegre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03915938    
Other Study ID Numbers: 15-0019
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Ketamine
ERP
Oddball
Additional relevant MeSH terms:
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Chronic Pain
Acute Pain
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action