Effect of Perioperative i.v. Low-dose S(+) Ketamine
1 other identifier
interventional
83
1 country
1
Brief Summary
The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain. Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2006
Typical duration for phase_4
1 active site
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
First Submitted
Initial submission to the registry
July 18, 2006
CompletedFirst Posted
Study publicly available on registry
July 19, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
July 20, 2011
CompletedJuly 20, 2011
July 1, 2011
1.8 years
July 18, 2006
May 24, 2011
July 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NRS Pain = Numeric Rating Scale (0-10)
The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.
24 hours
Study Arms (2)
Placebo
PLACEBO COMPARATORSaline 0,9%
S (+) Ketamine
ACTIVE COMPARATORInterventions
0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of disc prolapse
- Age 18+
- ASA (American Society in Anesthesiology) I-II
- written consent
You may not qualify if:
- Age \< 18
- ASA \> II
- liver failure
- renal failure
- heart failure
- glaucoma
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asker and Baerum Hospital
Rud, N-1309, Norway
Related Publications (3)
Arendt-Nielsen L, Nielsen J, Petersen-Felix S, Schnider TW, Zbinden AM. Effect of racemic mixture and the (S+)-isomer of ketamine on temporal and spatial summation of pain. Br J Anaesth. 1996 Nov;77(5):625-31. doi: 10.1093/bja/77.5.625.
PMID: 8957979BACKGROUNDHimmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. doi: 10.1097/00000542-200501000-00030. No abstract available.
PMID: 15618805BACKGROUNDBell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. doi: 10.1111/j.1399-6576.2005.00814.x.
PMID: 16223384BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ulrich J Spreng
- Organization
- Baerum Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrich J Spreng, Dr. med,
Asker and Baerum Hospital, Norway
- STUDY DIRECTOR
Vegard Dahl, Dr. med.
Asker and Baerum Hospital, Norway
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 18, 2006
First Posted
July 19, 2006
Study Start
August 1, 2006
Primary Completion
June 1, 2008
Study Completion
May 1, 2009
Last Updated
July 20, 2011
Results First Posted
July 20, 2011
Record last verified: 2011-07