NCT00753389

Brief Summary

This Germany-wide, multi-center, epidemiologic study is designed to evaluate the incidence of post-operative/anesthesia effects of muscle relaxants (i.e. post-operative residual curarization: PORC) and their effect on patient outcome. Aside from biometric data, type of operation, use of muscle relaxants and neuromuscular monitoring, all patients will be clinically evaluated after their operation in the post-anesthesia care unit. To look at long-term effects, patients will be followed-up 28 days after their operation/anesthesia regarding post-operative/anesthesia morbidity and mortality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

First QC Date

September 15, 2008

Last Update Submit

September 15, 2008

Conditions

Postoperative Residual Curarization

Keywords

Postoperative residual curarization,muscle relaxants,morbidity mortality

Outcome Measures

Primary Outcomes (1)

  • Survival

    28 days after anesthesia

Study Arms (1)

1

Other: None (anesthesia)

Interventions

None (anesthesia)OTHER

anesthesia

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving anesthesia

You may qualify if:

  • All patients attended by an anesthesiologist

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22

München, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Delayed Emergence from AnesthesiaMuscle Hypotonia

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Manfred Prof.Dr. Blobner, MD

    Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred Prof.Dr. Blobner, MD

CONTACT

0894140Blobner@lrz.tum.de

Heidrun Dr. Fink, MD

CONTACT

0894140h.fink@lrz.tum.de

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 16, 2008

Study Start

September 1, 2008

Study Completion

March 1, 2009

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

DE(1)