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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03915938
Other study ID # 15-0019
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 2, 2017
Est. completion date November 30, 2017

Study information

Verified date January 2018
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 30, 2017
Est. primary completion date November 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Intervention

Drug:
Ketamine
S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml
Placebo
Administered in an identical way than ketamine.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type Measure Description Time frame Safety issue
Other Subjective euphoria rating Euphoria will be rated using an analogue visual scale ranging of 0 to 10. up to 60 min
Other Subjective sedation rating Sedation will be rated using an analogue visual scale ranging of 0 (completely awake) to 100 (sleeping). up to 60 min
Primary 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
Secondary 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
Secondary Response times (behavioural oddball data) Response times to word classification in oddball task up to 60 min
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