Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients (ANA06103)
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|ClinicalTrials.gov Identifier: NCT00608621|
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : February 6, 2008
|Condition or disease|
Pain management is of major concern in the postoperative period, mostly based on opioids. In numerous experimental and clinical trials cholinergic mechanisms have been demonstrated to play an important antinociceptive role. Physostigmine, a central cholineresterase inhibitor, has been shown to produce analgesia and enhance opiate analgesia after systemic injection. This action is not based on µ-receptor (opioid) activity, but can be mostly explained by stimulation of serotonine (5-HT-3) receptors. The major withdrawal of utilizating physostigmine in postoperative care, is due to its short duration of action.
In the present study, we examined the effect of a continuous intavenous physostigmine application during a patient-controlled analgesia with piritramide for 48 hours compared to a placebo infusion with NaCl.
Major concern was set for consumption of analgesics, VAS-pain scale, hemodynamics, mobilisation and side effects.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Physostigmine 4 mg in 50 ml NaCl 0.9% per 24 h as syringe pump continuously for 48 hours, plus physostigmine 2mg (in NaCl 0.9% 50 ml)at termination of sedation
PCA: Patient-controlled analgesia with piritramide 1 mg/ml, on demand: bolus of 2 mg, maximum of 10 mg in 60 min
NaCl 0.9% 50 ml per 24 h continuously over 48 hours, plus 50 ml NaCl 0.9% at termination of sedation
PCA: Patient-controlled analgesia with piritramid 1 mg/ml, on demand: bolus of 2 mg, maximum of 10 mg in 60 min
- opioid consumption [ Time Frame: 48 hours ]
- pain quality (VAS) mobilisation hemodynamics side effects [ Time Frame: operation to discharge from hospital ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608621
|Klinkum Ludwigshafen, Department of Anesthesiology|
|Ludwigshafen, Germany, D-67063|
|Principal Investigator:||Christoph Konrad, Prof.||University Hospital Mannheim, Department of Anesthesiology|
|Study Director:||Kerstin D. Roehm, MD||Klinikum Ludwigshafen, Department of Anesthesiology|