Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 18, 2006
First Posted Date  ICMJE July 19, 2006
Results First Submitted Date  ICMJE May 24, 2011
Results First Posted Date  ICMJE July 20, 2011
Last Update Posted Date July 20, 2011
Study Start Date  ICMJE August 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2006)
Analgetic effect (VAS)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2006)
Satisfaction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Perioperative i.v. Low-dose S(+) Ketamine
Official Title  ICMJE Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemorrhoids
  • Pain
Intervention  ICMJE
  • Drug: S (+) Ketamine
    0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
  • Drug: Placebo
    isotonic saline
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Saline 0,9%
    Intervention: Drug: Placebo
  • Active Comparator: S (+) Ketamine
    Intervention: Drug: S (+) Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2009)
83
Original Enrollment  ICMJE
 (submitted: July 18, 2006)
50
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00354029
Other Study ID Numbers  ICMJE 2006-001082-41
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ulrich Johannes Spreng, Asker and Baerum Hospital
Study Sponsor  ICMJE Asker & Baerum Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulrich J Spreng, Dr. med, Asker and Baerum Hospital, Norway
Study Director: Vegard Dahl, Dr. med. Asker and Baerum Hospital, Norway
PRS Account Asker & Baerum Hospital
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP