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

A

Asker & Baerum Hospital

Status and phase

Completed
Phase 4

Conditions

Pain
Hemorrhoids

Treatments

Drug: Placebo
Drug: S (+) Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT00354029
2006-001082-41

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

83 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Saline 0,9%
Treatment:
Drug: Placebo
S (+) Ketamine
Active Comparator group
Treatment:
Drug: S (+) Ketamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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