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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-10-31

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.

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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.

Conditions

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Pain

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1-physostigmine

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

No interventions assigned to this group

2-placebo

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

No interventions assigned to this group

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No