The Preemptive Analgetic Potency of Low Dose S-Ketamine

Ketamine

Brief Summary

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

Intervention / Treatment

  • S-ketamine (DRUG)
    drug
  • Placebo Comparison (OTHER)
    saline control

Condition or Disease

  • Pain

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Feb 01, 2009
    Primary Completion: Mar 01, 2012 ACTUAL
    Completion Date: Sep 01, 2012 ACTUAL
    Study First Posted: Dec 01, 2009 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 01, 2012

    Sponsors / Collaborators

    Lead Sponsor: Medical University of Graz
    Responsible Party: N/A

    Location

    Graz, Styria, Austria

    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).

    Participant Groups

    • Placebo as saline solution

    • S-Ketamine

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • postoperative opioid consumption 1 year

    More Details

    NCT Number: NCT01022840
    Acronym: Miniket
    Other IDs: 180808
    Study URL: https://clinicaltrials.gov/study/NCT01022840
    Last updated: Sep 29, 2023