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CompletedNCT01022840MiniketUpdated Oct 2, 2012

The Preemptive Analgetic Potency of Low Dose S-Ketamine

A Phase 3 interventional study of S-Ketamine and Placebo Comparison in Pain, sponsored by Medical University of Graz. Completed at 3 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-02.

Sponsored by Medical University of Graz · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

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Conditions studied

  • Pain
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In context

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo as saline solution

    Other: Placebo Comparison

  • Experimental
    Low dose

    S-Ketamine

    Drug: S-Ketamine

  • Active comparator
    High dose

    Drug: S-Ketamine

Interventions

  • DrugS-Ketamine

    drug

    Also known as: Ketanest

  • OtherPlacebo Comparison

    saline control

    Also known as: Placebo

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What researchers measure

Primary outcomes

  1. postoperative opioid consumption

    Time frame: 1 year

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Study locations

3 sites
  • Medical University Graz
    Graz, Styria 8045, Austria
  • Medical University of Graz
    Graz, Styria 8045, Austria
  • Medical University of Graz
    Graz, 8036, Austria
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01022840
Lead sponsor
Medical University of Graz
Responsible party
Andreas Sandner-Kiesling , MD (Univ. Prof. Dr., Medical University of Graz) — Principal investigator
First posted
Dec 1, 2009
Start date
Feb 2009
Primary completion
Mar 2012
Completion
Sep 2012
Last update
Oct 2, 2012

Study contacts

Mischa Wejbora, MD
principal investigator · Med. U Graz

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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