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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreas Sandner-Kiesling , MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01022840
First received: November 21, 2009
Last updated: October 1, 2012
Last verified: October 2012
History of Changes

November 21, 2009
October 1, 2012
February 2009
March 2012   (final data collection date for primary outcome measure)
postoperative opioid consumption [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01022840 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Preemptive Analgetic Potency of Low Dose S-Ketamine
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.

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).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: S-Ketamine
    drug
    Other Name: Ketanest
  • Other: Placebo Comparison
    saline control
    Other Name: Placebo
  • Placebo Comparator: Placebo
    Placebo as saline solution
    Intervention: Other: Placebo Comparison
  • Experimental: Low dose
    S-Ketamine
    Intervention: Drug: S-Ketamine
  • Active Comparator: High dose
    Intervention: Drug: S-Ketamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01022840
180808
Yes
Andreas Sandner-Kiesling , MD, Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Mischa Wejbora, MD Med. U Graz
Medical University of Graz
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP