NCT00354029

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

Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Asker & Baerum Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoids
• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-06-01
• Completion: 2009-05-01
• First posted: 2006-07-19
• Last updated: 2011-07-20
• Results posted: 2011-07-20

Locations

1 site across 1 country: Norway