- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00753389
Muscle Relaxants and Post-Anesthesia Complications (PORC)
Epidemiologic Study on Short and Long-Term Effects of Anesthesia With Muscle Relaxants (Epidemiologische Untersuchung Kurz- Und längerfristiger Auswirkungen Der Anästhesie Mit Muskelrelaxanzien)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Muscle relaxants are integral part of modern anesthesia. They optimize intubating conditions, reduce laryngeal trauma and improve operating conditions. Drawback is a possible pharmacological (muscle relaxing) effect of these drugs beyond the end of the operation (i.e. post-operative residual curarization: PORC). PORC is a relevant complication after general anesthesia. Reportedly about 30% of all patients who received muscle relaxants show signs of PORC when arriving in the post-anesthesia care unit. PORC comprises the risk of impaired post-operative fine motor and coordinative skills with a possible impairment of swallowing pharyngeal secretions with an increased risk of aspiration after extubation. Possible deleterious effects of this could be pneumonia, bronchitis, myocardial infarction, cardiac insufficiency, stoke or re-operation. In a pilot study we were able to identify clinical assessment criteria to assess patients' risk for aspiration, which are now part of the post-anesthesia evaluation of every patient.
Unfortunately there is a major pitfall arising from the inability to clearly identify PORC. Although objective neuromuscular monitoring is the golden standard to measure neuromuscular transmission during anesthesia, clinical signs have been used to identify muscle weakness postoperatively. One reason for this practice is the varying action of muscle relaxants at different muscle groups demonstrating neuromuscular monitoring to be insufficiently sensitive to detect PORC symptoms at the pharyngeal muscles. This situation may lead to a seldom use of neuromuscular monitoring devices and may add to a decreasing use of muscle relaxants in clinical anesthesia.
In this Germany-wide, multi-center, epidemiologic study we would like to evaluate if the use of muscle relaxants, or signs of their prolonged effect beyond the end of the operation/anesthesia (PORC), affect the further in-hospital stay and post-operative morbidity and mortality. The sampling in 8 German hospitals should determine the number of patients with clinically relevant signs of muscle weakness at the time of arrival in the post-anesthesia care unit. Therefore a data entry form has been developed by the principal and sub-investigators of the 8 participating study hospitals. This data entry form enables the staff in charge of the post-anesthesia care unit to acquire and to document residual neuromuscular blockades. The sampling will be done in the 8 participating hospitals on 21 randomized working days over a period of 24 hours. To identify the potential risk factors for postoperative residual curarization, the known predictors for neuromuscular rest blockades are recorded as well. Known predictors are for example: type and amount of muscle relaxant, duration of operation and anesthesia, surgical procedure, patients' age, anesthesia-technique, antagonization of muscle relaxant or neuromuscular monitoring. Further, the patients' progress in the post-anesthesia care unit is documented.
The 28 day outcome of patients is followed up with a second data entry form which includes health-economical aspects. Reported are complications, duration of intensive care unit and hospital stay, as well as remaining health damages at the time of discharge. To estimate the significance of PORC, data of patients with PORC is compared to data of patients without PORC. These patients are recruited during the first data collection period in the post-anesthesia care unit. The control for any patient with PORC is the next one arriving in the post-anesthesia care unit without PORC.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Manfred Prof.Dr. Blobner, MD
- Phone Number: 7206 0894140
- Email: Blobner@lrz.tum.de
Study Contact Backup
- Name: Heidrun Dr. Fink, MD
- Phone Number: 6289 0894140
- Email: h.fink@lrz.tum.de
Study Locations
-
-
Bavaria
-
München, Bavaria, Germany, 81675
- Recruiting
- Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22
-
Contact:
- Manfred Prof. Dr. Blobner, MD
- Phone Number: 7206 +49894140
- Email: Blobner@lrz.tum.de
-
Contact:
- Heidrun Dr. Fink, MD
- Phone Number: 6289 +49894140
- Email: h.fink@lrz.tum.de
-
Principal Investigator:
- Manfred Prof. Blobner, MD
-
Sub-Investigator:
- Götz Prof. Geldner, MD
-
Sub-Investigator:
- Gabriele Prof. Nölge- Schomburg, MD
-
Sub-Investigator:
- Thomas Prof. Standl, MD
-
Sub-Investigator:
- Hugo Prof. van Aken, MD
-
Sub-Investigator:
- Friedrich Prof. Pühringer, MD
-
Sub-Investigator:
- Jens Prof. Scholz, MD
-
Sub-Investigator:
- Alexander PD. Dr. Schleppers, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients attended by an anesthesiologist
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
|
anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: 28 days after anesthesia
|
28 days after anesthesia
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manfred Prof.Dr. Blobner, MD, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PORC_main
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Residual Curarization
-
Peking University First HospitalXiangya Hospital of Central South University; Peking Union Medical College... and other collaboratorsUnknownPerioperative/Postoperative Complications | PORC (Postoperative Residual Curarization)China
-
Iuliu Hatieganu University of Medicine and PharmacyUnknownIncidence of Postoperative Residual Curarization
-
Xinmin WuMerck Sharp & Dohme LLCCompletedResidual CurarizationChina
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruiting
-
Azienda Ospedaliera di PadovaCompletedPostoperative Residual Curarization | Residual Neuromuscular BlockItaly
-
Poitiers University HospitalCompletedNeuromuscular Residual CurarizationFrance
-
University of Colorado, DenverRecruitingPostoperative Residual Curarization | Kidney Transplant; Complications | Postoperative Residual WeaknessUnited States
-
Beth Israel Deaconess Medical CenterCompletedPostoperative Respiratory Complication | Residual Neuromuscular Blockade | Curarization, Postoperative ResidualUnited States
-
General Administration of Military Health, TunisiaCompletedResidual CurarizationTunisia
-
Peking Union Medical College HospitalNot yet recruitingPostoperative Pulmonary Complications
Clinical Trials on None (anesthesia)
-
Bursa Yüksek İhtisas Education and Research HospitalRecruitingPneumonia, Viral | COVID-19 Pneumonia | EGFR AmplificationTurkey
-
Peking University First HospitalActive, not recruitingSARS-CoV-2 Infection | Hematologic MalignancyChina
-
Acibadem UniversityCompleted
-
Acibadem UniversityCompleted
-
Universidad Católica del MauleFondo Nacional de Desarrollo Científico y Tecnológico, ChileCompletedMental Disorders | Suicide, AttemptedChile
-
Shanghai Mental Health CenterUnknownSchizophrenia | ViolenceChina
-
Sir Run Run Shaw HospitalCompleted
-
Sir Run Run Shaw HospitalUnknown
-
University of BristolMedical Research Council; Wellcome Trust; Bristol Biomedical Research UnitCompletedPregnancy Related | Dietary Habits | Lead Poisoning
-
Azienda Ospedaliero Universitaria Maggiore della...CompletedChronic Kidney Diseases