Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients (ANA06103)
The study is to evaluate the influence of physostigmine in the postoperative period in intensive care patients considering pain quality, opioid consumption, hemodynamics and mobilisation.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function|
- opioid consumption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- pain quality (VAS) mobilisation hemodynamics side effects [ Time Frame: operation to discharge from hospital ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|