Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients, Considering Pain Score, Opioid Consumption, Hemodynamics and Cognitive Function

Conditions
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Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Indication for postoperative pain therapy and admission to ICU ASA I-III Weight 50-125 kg Patients that are willing to participate in the present study Exclusion Criteria: Peridural anesthesia for pain management Severe left ventricular function (EF <30%) Severe/exacerbated COPD; Asthma ASA IV-V Chronic renal insufficiency(Creatinine > 1,5 mg/dl) Ulcera ventriculi Known allergy to any of the study agents Hb preoperative <9,5 g/dl Alcohol,drug and/or tablet abuse (Opioids, NSAR) Emergency operation Pregnancy Women of childbearing age and without a negative pregnancy test Severe liver disease (GOT oder GPT > 45 U/L) Severe neurologica derangements (e.g. M. Parkinson, Multiple Sklerosis) History of apoplexia <6 Monate or residua Perioperative myocardial infarction Patients that are not able to agree to the present study Patients that refuse to participate in the present study Patients that are part of any other study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-physostigmine<br>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 | |
| 2-placebo<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain quality (VAS) mobilisation hemodynamics side effects |  | operation to discharge from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physostigmine, postoperative analgesia, pain, patient-controlled analgesia, Opioid consumption, Pain quality (VAS Score), Hemodynamics, Mobilisation, Side effects