The Preemptive Analgetic Potency of Low Dose S-Ketamine

Phase 3

Completed

• Conditions: Pain
• Interventions: Other: Placebo Comparison; Drug: S-Ketamine

• Registration Number: NCT01022840
• Lead Sponsor: Medical University of Graz

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-11-21
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2012-03
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Comparison	Placebo as saline solution
High dose	S-Ketamine	-
Low dose	S-Ketamine	S-Ketamine

Primary Outcome Measures

Name	Time	Method
postoperative opioid consumption	1 year

Trial Locations

Locations (2)

Medical University of Graz; 🇦🇹 Graz, Austria

Medical University Graz; 🇦🇹 Graz, Styria, Austria