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

NCT ID: NCT00354029

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-05-31

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.

Conditions

Hemorrhoids; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Saline 0,9%

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

isotonic saline

S (+) Ketamine

Group Type: ACTIVE_COMPARATOR

S (+) Ketamine

Intervention Type: DRUG

0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery

Interventions

S (+) Ketamine

0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery

Intervention Type: DRUG

Placebo

isotonic saline

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asker & Baerum Hospital

OTHER

Sponsor Role: lead

Responsible Party

Asker and Baerum Hospital

Principal Investigators

Ulrich J Spreng, Dr. med,

Role: PRINCIPAL_INVESTIGATOR

Asker and Baerum Hospital, Norway

Vegard Dahl, Dr. med.

Role: STUDY_DIRECTOR

Asker and Baerum Hospital, Norway

Locations

Asker and Baerum Hospital

Rud, , Norway

Countries

Norway

References

Arendt-Nielsen L, Nielsen J, Petersen-Felix S, Schnider TW, Zbinden AM. Effect of racemic mixture and the (S+)-isomer of ketamine on temporal and spatial summation of pain. Br J Anaesth. 1996 Nov;77(5):625-31. doi: 10.1093/bja/77.5.625.

Reference Type: BACKGROUND

PMID: 8957979 (View on PubMed)

Himmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. doi: 10.1097/00000542-200501000-00030. No abstract available.

Reference Type: BACKGROUND

PMID: 15618805 (View on PubMed)

Bell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. doi: 10.1111/j.1399-6576.2005.00814.x.

Reference Type: BACKGROUND

PMID: 16223384 (View on PubMed)

Other Identifiers

2006-001082-41

Identifier Type: -

Identifier Source: org_study_id