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