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Effect of Perioperative i.v. Low-dose S(+) Ketamine

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ClinicalTrials.gov Identifier: NCT00354029
Recruitment Status : Completed
First Posted : July 19, 2006
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Asker & Baerum Hospital

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.


Condition or disease Intervention/treatment Phase
Hemorrhoids Pain Drug: S (+) Ketamine Drug: Placebo Phase 4

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 N-Methyl-D-Aspartat (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 fewer 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy
Study Start Date : August 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
Drug Information available for: Ketamine
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Saline 0,9%
Drug: Placebo
isotonic saline
Active Comparator: S (+) Ketamine Drug: S (+) Ketamine
0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery



Primary Outcome Measures :
  1. NRS Pain = Numeric Rating Scale (0-10) [ Time Frame: 24 hours ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of disc prolapse
  • Age 18+
  • ASA (American Society in Anesthesiology) I-II
  • written consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00354029     History of Changes
Other Study ID Numbers: 2006-001082-41
First Posted: July 19, 2006    Key Record Dates
Results First Posted: July 20, 2011
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Asker & Baerum Hospital:
hemorrhoids
hemorrhoidectomy
S (+) ketamine
pain

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action