The Preemptive Analgetic Potency of Low Dose S-Ketamine | NCT01022840

Studies
The Preemptive Analgetic Potency of Low Dose S-Ketamine

NCT01022840

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Oct 2, 2012Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Pain

Interventions

S-Ketamine
Placebo Comparison

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Mar 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 21, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2012

Last Update Posted Date

Oct 2, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Sandner-Kiesling , MD, Univ. Prof. Dr., Medical University of GrazPrincipal Investigator

Lead Sponsor

Medical University of GrazOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo as saline solution	Other: Placebo Comparison
Low dose	Experimental	S-Ketamine	Drug: S-Ketamine
High dose	Active Comparator		Drug: S-Ketamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-Ketamine	Drug	drug	High dose Low dose	Ketanest

Measure	Description	Time Frame
postoperative opioid consumption		1 year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mischa Wejbora, MD	Med. U Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Graz		Graz	Styria	8045	Austria
Medical University of Graz

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000629870	Esketamine
D007649	Ketamine

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided