Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit (NCT02226809) | Clinical Trial Compass
CompletedNot Applicable
Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit
Spain763 participantsStarted 2014-06
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients \>18 years-old
* General anesthesia with non-depolarizing NMBA
* Transferred extubated on spontaneous ventilation to the PACU
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
Timeframe: Upon arrival to the PACU. Single evaluation.