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

Sponsor

Klinikum Ludwigshafen (Other)

Overall Status

Completed

CT.gov ID

NCT00608621

Collaborator

University of Mannheim (Other)

Enrollment

Location

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

opioid consumption [48 hours]

Secondary Outcome Measures

pain quality (VAS) mobilisation hemodynamics side effects [operation to discharge from hospital]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinkum Ludwigshafen, Department of Anesthesiology	Ludwigshafen		Germany	D-67063

Sponsors and Collaborators

Klinikum Ludwigshafen
University of Mannheim

Investigators

Principal Investigator: Christoph Konrad, Prof., University Hospital Mannheim, Department of Anesthesiology
Study Director: Kerstin D. Roehm, MD, Klinikum Ludwigshafen, Department of Anesthesiology