Effect of Perioperative i.v. Low-Dose S(+) Ketamine - Full Text View

Sponsor:	Asker & Baerum Hospital
Information provided by:	Asker & Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00354029

Purpose

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.

Condition	Intervention	Phase
Hemorrhoids	Drug: S (+) Ketamine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Effect of Perioperative i.v. Low-Dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:

Analgetic effect (VAS) [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Satisfaction [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	August 2006
Study Completion Date:	May 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

0,35 mg/kg bolus; 5 ug/kg/min. continuous

Detailed Description:

The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a NMDA receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fever side-effects.

The purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period.

The hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function.

The study is including patients undergoing hemorrhoidectomy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of disc prolapse
Age 18+
ASA I-II
written consent

Exclusion Criteria:

Age < 18
ASA > II
liver failure
renal failure
heart failure
glaucoma
pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354029

Locations

Norway
Asker and Baerum Hospital
Rud, Norway, N-1309

Sponsors and Collaborators

Asker & Baerum Hospital

Investigators

Principal Investigator:	Ulrich J Spreng, Dr. med,	Asker and Baerum Hospital, Norway
Study Director:	Vegard Dahl, Dr. med.	Asker and Baerum Hospital, Norway

More Information

Publications:

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.

Himmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. Review. No abstract available.

Bell 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. Review.

Responsible Party:	Asker and Baerum Hospital ( Ulrich Johannes Spreng )
Study ID Numbers:	2006-001082-41
Study First Received:	July 18, 2006
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00354029 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:

hemorrhoids
hemorrhoidectomy
S (+) ketamine

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions

Anesthetics, Dissociative
Digestive System Diseases
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Hemorrhoids
Ketamine
Cardiovascular Diseases
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 20, 2009