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

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.

Intervention / Treatment

  • S (+) Ketamine (DRUG)
    0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
  • Placebo (DRUG)
    isotonic saline

Condition or Disease

  • Hemorrhoids
  • Pain

Phase

Study Design

Study type: INTERVENTIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 83 (ACTUAL)
Funded by: Other
Allocation: Randomized
Primary Purpose: Treatment

Masking

Clinical Trial Dates

Start date: Aug 01, 2006
Primary Completion: Jun 01, 2008 ACTUAL
Completion Date: May 01, 2009 ACTUAL
Study First Posted: Jul 19, 2006 ESTIMATED
Results First Posted: Jul 20, 2011 ESTIMATED
Last Updated: Jul 19, 2011

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

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 Criteria

Sex: All
Minimum Age: 18
Healthy Volunteers: Yes

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

Primary Outcomes
  • 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.

More Details

NCT Number: NCT00354029
Other IDs: 2006-001082-41
Study URL: https://clinicaltrials.gov/study/NCT00354029
Last updated: Sep 29, 2023