Postoperative Residual CurarizationPORCNCT00753389
Muscle Relaxants and Post-Anesthesia Complications
An observational study of Postoperative Residual Curarization, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Residual Curarization
- What is being tested?
- None (anesthesia)
- How many people
- 20,000 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receiving anesthesia
Who may be able to join
- All patients attended by an anesthesiologist
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22
München, Bavaria, 81675
Manfred Prof. Dr. Blobner, MD, +49894140 ext. 7206, Blobner@lrz.tum.de
Heidrun Dr. Fink, MD, +49894140 ext. 6289, h.fink@lrz.tum.de
About this study
Official title: Epidemiologic Study on Short and Long-Term Effects of Anesthesia With Muscle Relaxants (Epidemiologische Untersuchung Kurz- Und längerfristiger Auswirkungen Der Anästhesie Mit Muskelrelaxanzien)
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.
Read the 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.
- Conditions
- Postoperative Residual Curarization
- Being tested
- None (anesthesia)
- Keywords
- Postoperative residual curarization,, muscle relaxants,, morbidity mortality
- Medical subject headings
- Delayed Emergence from Anesthesia, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (anesthesia)Other
anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: None (anesthesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 28 days after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startSep 2008
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Residual CurarizationStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Manfred Prof.Dr. Blobner, MD, Principal investigator, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753389
- Sponsor's protocol ID
- PORC_main
- Acronym
- PORC
- Status last verified
- Sep 2008
- First submitted
- 15 Sep 2008
- Last updated
- 16 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study on Short and Long-Term Effects of Anesthesia With Muscle Relaxants (Epidemiologische Untersuchung Kurz- Und längerfristiger Auswirkungen Der Anästhesie Mit Muskelrelaxanzien)
- ClinicalTrials.gov ID
- NCT00753389
- Acronym / sponsor ID
- PORC / PORC_main
- Conditions
- Postoperative Residual Curarization
- Keywords
- Postoperative residual curarization,, muscle relaxants,, morbidity mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Sep 2008
- Study completion
- Mar 2009 (estimated)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: None (anesthesia) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving anesthesia
Key inclusion criteria (1 listed)
- All patients attended by an anesthesiologist
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (anesthesia)anesthesia | Other | 1 |
Primary outcome
Survival
Time frame: 28 days after anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Prof.Dr. Blobner, MD principal investigator
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Residual Curarization, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manfred Prof.Dr. Blobner, MD (0894140 ext. 7206, Blobner@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 28 days after anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2008.