To study the time needed for full recovery of carotid body response to hypoxia (ie. hypoxic ventilatory response, HVR) after full recovery of neuromuscular block with and without reversal with sugammadex
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
perioperatieve verslapping
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end-point is the time difference to full recovery of the hypoxic
ventilatory response after recovery of NMB
Secondary outcome
The dynamics of carotid body function at different levels of NMB and during
recovery.
The influence of sugammadex reversal on CB function recovery
Background summary
The ventilatory response to hypoxia is a life-saving chemoreflex that
originates from the carotid bodies. Dysfunction of this reflex renders patients
at risk for respiratory adverse events such as hypoxia. Numerous drugs depress
this reflex, including muscle relaxants which are routinely used during general
anesthesia. Muscle relaxants directly block acetylcholine mediate signal
transmission at the carotid bodies and they do so even at very low
concentrations. In addition, data from the BREATH trial showed that, even after
full recovery of neuromuscular block, the ventilatory response to hypoxia has
not recovered fully in a significant subset of subjects.
Study objective
To study the time needed for full recovery of carotid body response to hypoxia
(ie. hypoxic ventilatory response, HVR) after full recovery of neuromuscular
block with and without reversal with sugammadex
Study design
randomized, cross over, experimental trial
Study burden and risks
The administration of a low dose of rocuronium leads to some degree of muscle
relaxation (TOF ratio remains 0.7 or higher).
Similar muscle relaxation also occurs in postoperative patients. This degree of
muscle relaxation generally induces, diplopia and dysarthria.
Given the presence of a doctor, the continuous monitoring of vital signs and
the possibility of immediate reversal of the neuromuscular block, the direct
risks are minimal.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Age: >18 years old
Exclusion criteria
BMI index; >30 kg/m2
Known or suspected neuromuscular disorders impairing neuromuscular function;
Allergies to muscle relaxants, anesthetics or narcotics;
A (family) history of malignant hyperthermia or any other muscle disease;
Any neurological or psychiatric illness (including a history of anxiety).
ASA class 3 or higher
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-000057-27-NL |
| CCMO | NL78678.058.21 |