The effect of deep muscle relaxation on the abdominal working space during laparosopy, measured by MRI.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The abdominal working space space measured by MRI: Skin - sacral promontory
distance
Secondary outcome
The abdominal working space space measured by MRI: 3D volume of the abdominal
cavity
Background summary
Patient safety during laparoscopy has great priority. Recent studies using deep
muscle relaxation showed that surgeons prefer deep neuromuscular blockade,
because of improved surgical space conditions. Several animal studies, which
assessed the influence of neuromuscular blockade on the intra-abdominal space
in pigs, did not support these outcomes. They doubt the reliability of the
subjective surgeon-rated quality of the surgical field. Therefore we will
assess the effects of deep neuromuscular blockade during laparoscopy on the
abdominal space, measured by MRI.
Study objective
The effect of deep muscle relaxation on the abdominal working space during
laparosopy, measured by MRI.
Study design
Single center study
Prospective cohort study
Intervention
Following induction of general anesthesia and creation of pneumoperitoneum,
each patiƫnt will undergo a MRI scan in 3 phases
(total duration 30 minutes)
- phase 1: no NMB (first scan)
- phase 2: moderate NMB (second scan)
- phase 3: deep NMB (third scan)
Study burden and risks
Minimal burden, since the assessment of the effects of deep neuromuscular
blockade during surgery are performed during general anesthesia. The MRI will
be performed during general anesthesia, which will be lengthened with
approximately 30 minutes.
Negligible risk, with a small chance of minimal harm.
The extended effects of deep neuromuscular blockade can lead to post-operative
complications, such as airway obstruction, hypoxia, pneumonia and/or
atelectasis. Therefore, sugammadex, a rapid antagonist of neuromuscular
blockade is given immediately after surgery. Randomized controlled trials have
shown that sugammadex can be safely administered in patients.
Geerty Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geerty Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- all adult patients (18 years or older) scheduled for laparoscopic donor nephrectomy
- obtained informed consent
Exclusion criteria
* Unable to provide informed consent
* known or suspect allergy to mivacurium, rocuronium or sugammadex
* neuromuscular disease
* indication for rapid sequence induction
* Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants, epilepsy)
* Deficiency of vitamin K-dependent clotting factors, coagulopathy or active use of coumarin derivates.
* Peri-operative use of fusidic acid or flucloxacilline
* Severe renal impairment (creatinine clearance <30ml/min)
* BMI> 30 kg/m2
* ASA-score > 2
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2017-003623-29-NL |
ClinicalTrials.gov | NCT03287388 |
CCMO | NL63227.091.17 |