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Miniket: The Preemptive Analgetic Potency of Low Dose S-Ketamine

Sponsor
Medical University of Graz (Other)
Overall Status
Completed
CT.gov ID
NCT01022840
Collaborator
(none)
60
Enrollment
3
Locations
3
Arms
43
Duration (Months)
20
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Active Comparator: High dose

    Drug: S-Ketamine
    drug
    Other Names:
  • Ketanest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative opioid consumption [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University Graz Graz Styria Austria 8045
    2 Medical University of Graz Graz Styria Austria 8045
    3 Medical University of Graz Graz Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andreas Sandner-Kiesling , MD, Univ. Prof. Dr., Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT01022840
    Other Study ID Numbers:
    • 180808
    First Posted:
    Dec 1, 2009
    Last Update Posted:
    Oct 2, 2012
    Last Verified:
    Oct 1, 2012
    Additional relevant MeSH terms:
    Ketamine
    Esketamine

    Study Results

    No Results Posted as of Oct 2, 2012