Incomplete Reversal of Neuromuscular BlockReCuSSNCT02226809
Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit
An observational study of Incomplete Reversal of Neuromuscular Block and Postoperative Respiratory Complications, run by University of Valencia at 25 sites in Spain.
Trial summary
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. The incidence is variable due to multiple factors. In Spain the incidence is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incomplete Reversal of Neuromuscular Block, Postoperative Respiratory Complications
- What is being tested?
- Accelerometry
- Type of treatment
- Medical device
- How many people
- 763 participants
- Where
- 25 sitesSpain
- Study dates
- Jun 2014to Jul 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients under general anesthesia
Who may be able to join
- Patients >18 years-old
- General anesthesia with non-depolarizing NMBA
- Transferred extubated on spontaneous ventilation to the PACU
Who cannot join
- American Society of Anesthesiologists physical status IV-V
- emergency and cardiac surgery
- patients unable to respond adequately at the moment of pre- or postoperative evaluation (psychiatric diseases, excessive somnolence, agitation, etc.)
- noncompensated diabetes mellitus or diabetic neuropathy
- symptomatic severe hypothyroidism (or untreated), or scheduled for total thyroidectomy
- chronic or acute renal insufficiency
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- severe hepatopathy (Child-Pugh B, C)
- intraoperative blood transfusion >3 blood units
- intraoperative maintained arterial hypotension
- arrival to the PACU intubated or with instrumented airway (including surgical)
- pre- or perioperative drugs intake affecting the neuromuscular transmission
- neuromuscular diseases affecting the physiology of the neuromuscular system
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Complejo Hospitalario Universitario
A Coruña, Coruña, 15006
Hospital de Bellvitge
Badalona, Barcelona, 08907
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clinic Universitari
Barcelona, Barcelona, 08036
Hospital Universitario Basurto
Basurto, Vizcaya, 48013
Hospital General de Castellón
Castellon, Castellón, 12004
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004
Hospital General de Elda
Elda, Alicante, 03600
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital San Pedro
Logroño, La Rioja, 26006
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Hospital Universitario de la Princesa
Madrid, Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital de Manacor
Manacor, Palma de Mallorca, 07500
Hospital Universitario Son Espases
Palma de Mallorca, Palma de Mallorca, 07010
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
Hospital Universitario Dr Peset
Valencia, Valencia, 46017
Hospital Universitario Politécnico La Fe
Valencia, Valencia, 46026
Hospital Xeral de Vigo
Vigo, Pontevedra, 36204
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
Official title: Incidence of Residual Neuromuscular Block in Adult Patients in the Postanesthesia Care Unit. An Observational Cross-sectional Study of a Multicenter Cohort. The Residual Curarization in Spain Study (ReCuSS).
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. The incidence is variable due to multiple factors. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular block agents (NMBA).
The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
Read the detailed description
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. This includes recovery delay or hospital discharge delays, respiratory insufficiency or infections, unforeseen ICU admissions, and prolonged ICU stays.
The incidence is variable due to multiple factors. Age, gender, surgery, NMBA type and doses, temperature, medications, etc.
In several studies it has been found and incidence between 6-80%. Few studies have been focused in evaluating the incidence in the whole country, as representing a global anesthesia practice. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action NMBA.
The main objective is to know the incidence of RNMB in Spanish hospitals, by means of an observational cross-sectional multicenter study .
Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
- Being tested
- Accelerometry
- Keywords
- Muscle relaxants, Postoperative complications, respiratory, General anesthesia, Postanesthesia care unit, Neuromuscular block reversal
- Medical subject headings
- Muscle Hypotonia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometryDevice
Also called TOF-Watch
Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Evaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose Receives: Device: Accelerometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
Patients operated on under general anesthesia including intermediate duration NMBA were evaluated by means of an accelerometer in the PACU immediately upon arrival. Train-of-four ratio (TOFr) is evaluated.
The evaluator does'nt know the patient-related information, including intraoperative management.
Measured: Upon arrival to the PACU. Single evaluation.
Secondary outcomes (1)
Respiratory or airway postoperative complications in the PACU
Evaluation of respiratory complications or events in the PACU (asking the anesthesiologist in charge or PACU medical record) to discharge to the ward.
Measured: During PACU stay, an expected average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete Reversal of Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 763 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital of Valencia, Hospital General Universitario Gregorio Marañon
- Responsible party
- Principal investigator, Carlos Luis Errando, General University Hospital of Valencia
- Investigators
- Carlos L Errando, MD, PhD, Principal investigator, Servicio de Anestesiologia. Consorcio Hospital General Universitario de ValenciaIgnacio Garutti, MD, PhD, Principal investigator, Servicio de Anestesiologia. Hospital Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226809
- Sponsor's protocol ID
- CEO-BNM-2014-01
- Acronym
- ReCuSS
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Residual Neuromuscular Block in Adult Patients in the Postanesthesia Care Unit. An Observational Cross-sectional Study of a Multicenter Cohort. The Residual Curarization in Spain Study (ReCuSS).
- ClinicalTrials.gov ID
- NCT02226809
- Acronym / sponsor ID
- ReCuSS / CEO-BNM-2014-01
- Keywords
- Muscle relaxants, Postoperative complications, respiratory, General anesthesia, Postanesthesia care unit, Neuromuscular block reversal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 763 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- General University Hospital of Valencia, Hospital General Universitario Gregorio Marañon
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Aug 2014 (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.
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. The incidence is variable due to multiple factors. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular block agents (NMBA).
The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
Detailed description
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. This includes recovery delay or hospital discharge delays, respiratory insufficiency or infections, unforeseen ICU admissions, and prolonged ICU stays.
The incidence is variable due to multiple factors. Age, gender, surgery, NMBA type and doses, temperature, medications, etc.
In several studies it has been found and incidence between 6-80%. Few studies have been focused in evaluating the incidence in the whole country, as representing a global anesthesia practice. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action NMBA.
The main objective is to know the incidence of RNMB in Spanish hospitals, by means of an observational cross-sectional multicenter study .
Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | Device: AccelerometryEvaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients under general anesthesia
Key inclusion criteria (3 listed)
- Patients >18 years-old
- General anesthesia with non-depolarizing NMBA
- Transferred extubated on spontaneous ventilation to the PACU
Key exclusion criteria (12 listed)
- American Society of Anesthesiologists physical status IV-V
- emergency and cardiac surgery
- patients unable to respond adequately at the moment of pre- or postoperative evaluation (psychiatric diseases, excessive somnolence, agitation, etc.)
- noncompensated diabetes mellitus or diabetic neuropathy
- symptomatic severe hypothyroidism (or untreated), or scheduled for total thyroidectomy
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 |
|---|---|---|
| AccelerometryAlso: TOF-WatchApplication of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU | Device | General anesthesia |
Primary outcome
Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
Time frame: Upon arrival to the PACU. Single evaluation.
Patients operated on under general anesthesia including intermediate duration NMBA were evaluated by means of an accelerometer in the PACU immediately upon arrival. Train-of-four ratio (TOFr) is evaluated. The evaluator does'nt know the patient-related information, including intraoperative management.
1 secondary outcome
Respiratory or airway postoperative complications in the PACU
Time frame: During PACU stay, an expected average of 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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.
Carlos L Errando, MD, PhD principal investigator
Servicio de Anestesiologia. Consorcio Hospital General Universitario de Valencia
Ignacio Garutti, MD, PhD principal investigator
Servicio de Anestesiologia. Hospital Universitario Gregorio Marañon
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incomplete Reversal of Neuromuscular Block and Postoperative Respiratory Complications, run by University of Valencia at 25 sites in Spain.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU (time frame: Upon arrival to the PACU. Single evaluation.). 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 27 Aug 2014.