To assess whether a deep neuromuscular block provides better surgical conditions than a moderately deep block as derived from a surgical rating score.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
laparoscopische renale en prostaatchirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the surgical conditions in patients undergoing laparoscopic renal or
prostate surgery during deep versus less deep neuromuscular block as assessed
by the surgical rating score.
Secondary outcome
Postoperative sedation, pain and respiration
Background summary
A deep neuromuscular block is often associated with improved surgical
conditions especially in laparoscopic surgery. However, a deep block comes at
the expense of a variety of items that may conflict with the use of a deep
surgical muscle blockade including a long recovery phase, the need for muscle
reversal, postoperative ventilation, impaired postoperative breathing. With the
introduction of Sugammadex there is now the possibility to reverse an even deep
surgical block. This may overcome most if not all of the issues mentioned.
Study objective
To assess whether a deep neuromuscular block provides better surgical
conditions than a moderately deep block as derived from a surgical rating
score.
Study design
Single center, double-blind randomized controlled trial.
Study burden and risks
None related to the study
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients that will undergo elective laparoscopoc renal or prostate surgery
Exclusion criteria
(i) Known or suspected neuromuscular disorders impairing neuromuscular function;
(ii) Allergies to muscle relaxants, anesthetics or narcotics;
(iii) A (family) history of malignant hyperthermia;
(iv) Patients who have a contraindication for neostigmine administration;
(v) Women who are or may be pregnant or are currently breast feeding;
(vi) Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h. When available, other indices will be taken into account as well such as glomerular filtration rate < 60 ml/h and proteinuria (a ratio of 30 mg albumin to 1 g of creatinine).
(vii) Previous retroperitoneal surgery at the site of the current surgery.
(vii) Body mass index > 35 kg/m2
Design
Recruitment
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 |
|---|---|
| CCMO | NL40689.058.12 |