Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients (ANA06103)

Klinikum Ludwigshafen

Status: Completed

Conditions: Pain

Study type: Observational

Funder types: Other

Identifiers

NCT00608621

ANA06103

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

1-physostigmine

Description:

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

Description:

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