Physostigmine induced reduction of analgetic treatment (PIRAT trial): Randomisiert kontrollierte Doppelblind-Studie zur analgetischen Wirkung einer postoperativen systemischen Applikation von Physostigmin bei abdomineller Hysterektomie. - PIRAT

• Conditions: female patients in need of getting an abdominal hysterectomy due to an illness; MedDRA version: 9.1Level: LLTClassification code 10000075Term: Abdominal hysterectomy

• Registration Number: EUCTR2006-006839-51-DE
• Lead Sponsor: Dr. Franz Köhler Chemie GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

female with minimal age of 18 years
need to undergo abdominal hyterectomy under general anesthesia
written informed consent given

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•mechanical obstipation
•mechanical urinary retention
•gangrene
•dystophia myotonica
•depolarization block after application of depolarizing muscle relaxant
•intoxication by depolarizing muscle relaxant of the Suxamethonium type
•intoxication by irreversible acting cholinesterase inhibitors
•enclosed craniocerebral injury
•obstruction of the gastrointestinal tract and the revulsive urinary tract
•current known allergic asthma bronchial or hostory of allergic asthma bronchiale
•current serious diseases according ASA score > II esp. cardio- or cerebral vascular or pulmonary diseases
•incapability of giving informed consent
•current regular analgesic intake (opioids WHO III or NSAID/non-opioids for > 15 days/months or daily intake for the 7 last days)
•Anaphylaxis on the active component or any athor component of Anticholium, Physostigminsalicylat (Ph.EUR.), Natriummetabisulfat (Ph.EUR.), placebo, Dipidolor, Metamizol or any other component of the IMP
•Any surgery with persitent complaints within the last 2 months (exemption conization)
•Recent history (6 months) or current evidence of alcohol or drug abuse;
•Participation iin any other investigational drug therapy study within the last 90 days
•Breastfeeding women
•Body weight above 130 kg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified