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

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

Tracking Information

• First Submitted Date: November 21, 2009
• First Posted Date: December 1, 2009
• Last Update Posted Date: October 2, 2012
• Study Start Date: February 2009
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 30, 2009): postoperative opioid consumption [ Time Frame: 1 year ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01022840 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Preemptive Analgetic Potency of Low Dose S-Ketamine
• 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)
• Brief Summary: The primary hypothesis is improved postoperative analgetic quality using S-Ketamine, particularly in patients suffering from chronic pain.
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain

Intervention

• Drug: S-Ketamine
  drug
  Other Name: Ketanest
• Other: Placebo Comparison
  saline control
  Other Name: Placebo

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2009): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2012
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT01022840
• Other Study ID Numbers: 180808
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Andreas Sandner-Kiesling , MD, Medical University of Graz
• Study Sponsor: Medical University of Graz
• Collaborators: Not Provided

Investigators

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

• PRS Account: Medical University of Graz
• Verification Date: October 2012