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| Sponsored by: |
Asker & Baerum Hospital |
|---|---|
| Information provided by: | Asker & Baerum Hospital |
| ClinicalTrials.gov Identifier: | NCT00354029 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemorrhoids |
Drug: S (+) Ketamine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Effect of Perioperative i.v. Low-Dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy |
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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 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 fever 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ulrich J Spreng, Dr. med. | 47-6780-9400 | ulrich.spreng@sabhf.no |
| Contact: Vegard Dahl, Dr. med. | 47-6780-9400 | vegard.dahl@sabhf.no |
| Norway | |
| Asker and Baerum Hospital | Recruiting |
| Rud, Norway, N-1309 | |
| Contact: Ulrich J Spreng, Dr. med. 47-6780-9400 ulrich.spreng@sabhf.no | |
| Principal Investigator: Ulrich/ J Spreng, Dr. med. | |
| Principal Investigator: | Ulrich J Spreng, Dr. med, | Asker and Baerum Hospital, Norway |
| Study Director: | Vegard Dahl, Dr. med. | Asker and Baerum Hospital, Norway |
More Information
| Responsible Party: | Asker and Baerum Hospital ( Ulrich Johannes Spreng ) |
| Study ID Numbers: | 2006-001082-41 |
| Study First Received: | July 18, 2006 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00354029 |
| Health Authority: | Norway: Norwegian Medicines Agency |
|
hemorrhoids hemorrhoidectomy S (+) ketamine |
|
Excitatory Amino Acids Digestive System Diseases Gastrointestinal Diseases Ketamine |
Vascular Diseases Hemorrhoids Intestinal Diseases Rectal Diseases |
|
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Anesthetics, Dissociative Pharmacologic Actions |
Sensory System Agents Anesthetics, General Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Analgesics Central Nervous System Agents Excitatory Amino Acid Antagonists |
