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

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ClinicalTrials.gov Identifier: NCT01022840
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Andreas Sandner-Kiesling , MD, Medical University of Graz

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
Pain Drug: S-Ketamine Other: Placebo Comparison 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).

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Study Type : Interventional  (Clinical Trial)
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 : February 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo as saline solution
Other: Placebo Comparison
saline control
Other Name: Placebo

Experimental: Low dose
S-Ketamine
Drug: S-Ketamine
drug
Other Name: Ketanest

Active Comparator: High dose Drug: S-Ketamine
drug
Other Name: Ketanest




Primary Outcome Measures :
  1. postoperative opioid consumption [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022840


Locations
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Austria
Medical University Graz
Graz, Styria, Austria, 8045
Medical University of Graz
Graz, Styria, Austria, 8045
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Mischa Wejbora, MD Med. U Graz

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Responsible Party: Andreas Sandner-Kiesling , MD, Univ. Prof. Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01022840     History of Changes
Other Study ID Numbers: 180808
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
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Ketamine
Esketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Psychotropic Drugs