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

This study has been completed.
Sponsor:
Information provided by:
Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT00354029
First received: July 18, 2006
Last updated: July 19, 2011
Last verified: July 2011
  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
Pain
Drug: S (+) Ketamine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy

Resource links provided by NLM:


Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • NRS Pain = Numeric Rating Scale (0-10) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


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)
Arms Assigned Interventions
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

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.

  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 (American Society in Anesthesiology) I-II
  • written consent

Exclusion Criteria:

  • Age < 18
  • ASA > II
  • liver failure
  • renal failure
  • heart failure
  • glaucoma
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00354029     History of Changes
Other Study ID Numbers: 2006-001082-41
Study First Received: July 18, 2006
Results First Received: May 24, 2011
Last Updated: July 19, 2011
Health Authority: Norway: Norwegian Medicines Agency

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
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014