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The Preemptive Analgetic Potency of Low Dose S-Ketamine

NCT ID: NCT01022840

Last Updated: 2012-10-02

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

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-09-30

Brief Summary

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The primary hypothesis is improved postoperative analgetic quality using S-Ketamine, particularly in patients suffering from chronic pain.

Detailed Description

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The investigators are dealing mainly with the finding of the right dosage for the optimal safety and efficacy of S-Ketamine, but also discovering new possible areas of investigation (e.g. anti-depressive effect, anti-neuropathic effect).

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo as saline solution

Group Type PLACEBO_COMPARATOR

Placebo Comparison

Intervention Type OTHER

saline control

Low dose

S-Ketamine

Group Type EXPERIMENTAL

S-Ketamine

Intervention Type DRUG

drug

High dose

Group Type ACTIVE_COMPARATOR

S-Ketamine

Intervention Type DRUG

drug

Interventions

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S-Ketamine

drug

Intervention Type DRUG

Placebo Comparison

saline control

Intervention Type OTHER

Other Intervention Names

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Ketanest Placebo

Eligibility Criteria

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Inclusion Criteria

* Scheduled for major abdominal surgery
* Suitable for PCA
* Cardio-vascular stable
* Age: 18+
* Between 50-120kg BW
* ASA 1-3
* Good Compliance for pain monitoring

Exclusion Criteria

* Allergy to S-Ketamine
* Severe liver or kidney dysfunction
* Severe coronary disease
* Pregnancy
* Present or past psychotic disorders
* Addiction to alcohol or opioids
* Poor compliance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Andreas Sandner-Kiesling , MD

Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mischa Wejbora, MD

Role: PRINCIPAL_INVESTIGATOR

Med. U Graz

Locations

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Medical University Graz

Graz, Styria, Austria

Site Status

Medical University of Graz

Graz, Styria, Austria

Site Status

Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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180808

Identifier Type: -

Identifier Source: org_study_id