The Preemptive Analgetic Potency of Low Dose S-Ketamine (Miniket)

October 1, 2012 updated by: Andreas Sandner-Kiesling , MD, Medical University of Graz

The Opioid Sparing Effect of Minimal Dose S-Ketamine Applied as a Coanalgesic During the Perioperative Period - An Active Placebo-Controlled, Double Blinded, Randomized Clinical Trial (МiniKet)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz
    • Styria
      • Graz, Styria, Austria, 8045
        • Medical University Graz
      • Graz, Styria, Austria, 8045
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High dose
Drug: S-Ketamine
drug
Other Names:
  • Ketanest
Placebo Comparator: Placebo
Placebo as saline solution
Other: Placebo Comparison
saline control
Other Names:
  • Placebo
Experimental: Low dose
S-Ketamine
Drug: S-Ketamine
drug
Other Names:
  • Ketanest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative opioid consumption
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Mischa Wejbora, MD, Med. U Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 21, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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