NCT00608621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
Last Updated

February 6, 2008

Status Verified

December 1, 2007

Enrollment Period

9 months

First QC Date

January 23, 2008

Last Update Submit

February 5, 2008

Conditions

Pain

Keywords

physostigminepostoperative analgesiapainpatient-controlled analgesiaOpioid consumptionPain quality (VAS Score)HemodynamicsMobilisationSide effects

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    48 hours

Secondary Outcomes (1)

  • pain quality (VAS) mobilisation hemodynamics side effects

    operation to discharge from hospital

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elective major surgery, postoperative ICU patients

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinkum Ludwigshafen, Department of Anesthesiology

Ludwigshafen, D-67063, Germany

Location

Related Publications (5)

  • Beilin B, Bessler H, Papismedov L, Weinstock M, Shavit Y. Continuous physostigmine combined with morphine-based patient-controlled analgesia in the postoperative period. Acta Anaesthesiol Scand. 2005 Jan;49(1):78-84. doi: 10.1111/j.1399-6576.2004.00548.x.

    PMID: 15675987BACKGROUND

  • Rohm KD, Riechmann J, Boldt J, Schollhorn T, Piper SN. Retracted: Do patients profit from physostigmine in recovery from desflurane anaesthesia? Acta Anaesthesiol Scand. 2007 Mar;51(3):278-83. doi: 10.1111/j.1399-6576.2006.01238.x. Epub 2007 Jan 23.

    PMID: 17250745BACKGROUND

  • Aiello-Malmberg P, Bartolini A, Bartolini R, Galli A. Effects of morphine, physostigmine and raphe nuclei stimulation on 5-hydroxytryptamine release from the cerebral cortex of the cat. Br J Pharmacol. 1979 Apr;65(4):547-55. doi: 10.1111/j.1476-5381.1979.tb07863.x.

    PMID: 435680BACKGROUND

  • Passchier J, Rupreht J, Koenders ME, Olree M, Luitwieler RL, Bonke B. Patient-controlled analgesia (PCA) leads to more postoperative pain relief, but also to more fatigue and less vigour. Acta Anaesthesiol Scand. 1993 Oct;37(7):659-63. doi: 10.1111/j.1399-6576.1993.tb03784.x.

    PMID: 8249554BACKGROUND

  • Rupreht J, Schneck HJ, Dworacek B. [Physostigmine--recent pharmacologic data and their significance for practical use]. Anaesthesiol Reanim. 1989;14(4):235-41. German.

    PMID: 2675888BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Konrad, Prof.

    University Hospital Mannheim, Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

  • Kerstin D. Roehm, MD

    Klinikum Ludwigshafen, Department of Anesthesiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 6, 2008

Study Start

January 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 6, 2008

Record last verified: 2007-12

Locations

DE(1)