NCT01022840

Brief Summary

The primary hypothesis is improved postoperative analgetic quality using S-Ketamine, particularly in patients suffering from chronic pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3 pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 2, 2012

Status Verified

October 1, 2012

Enrollment Period

3.1 years

First QC Date

November 21, 2009

Last Update Submit

October 1, 2012

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative opioid consumption

    1 year

Study Arms (3)

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

S-KetamineDRUG

drug

Also known as: Ketanest
High doseLow dose
Placebo ComparisonOTHER

saline control

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical University Graz

Graz, Styria, 8045, Austria

Location

Medical University of Graz

Graz, Styria, 8045, Austria

Location

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Pain

Interventions

EsketamineKetamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Mischa Wejbora, MD

    Med. U Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr.

Study Record Dates

First Submitted

November 21, 2009

First Posted

December 1, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

October 2, 2012

Record last verified: 2012-10

Locations

AU(3)