Main objective To study the surgical conditions in patients undergoing laparoscopic renal or prostate surgery during deep versus moderate neuromuscular block as assessed by the Leiden Surgical Rating Scale.Minor objectives1. To study the hemodynamic…
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Brief title
Condition
- Other condition
Synonym
Health condition
anesthesie voor utrologische laparoscopische ingrepen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main end-point of the study is the effect of the deep block on surgical
conditions during sevoflurane anesthesia. To that end-the surgical team will be
asked to rate the quality of the surgical field at 15-min intervals using the
5-point Leiden-Surgical Rating Scale (L-SRS), a scale that was previously
developed at LUMC and recently validated
Secondary outcome
Secondary end-points of the study are hemodynamics (blood pressure and heart
rate) and Nociception Level (NoL [3]) during anesthesia, and pain and sedation
scores following surgery.
Background summary
In two independent studies we previously showed that deep NMB produces superior
surgical rating scores compared to a moderate NMB [1,2]. In retroperitoneal
surgery, for example, we showed that during propofol anesthesia deep NMB was
associated with a mean surgical rating scale (SRS) of 4.7 (on a 5-point scale)
compared to a score of 4.0 during moderate NMB. This difference was considered
highly significant by the surgeon. Since both studies were performed during
general anesthesia with the intravenous anesthetic propofol, it remains unknown
what the influence is of the anesthesia type on the SRS scores. Therefore we
will now study the effect of deep versus moderate NMB on SRS scores during
sevoflurane in retroperitoneal surgery. We expect a difference in SRS scores
albeit of smaller magnitude than in our first two studies since sevoflurane has
neuromuscular relaxing properties.
1. Martini M, Boon M, Bevers R, Aarts L, Dahan A. Evaluation of surgical
conditions during laparoscopic surgery in patients with moderate versus deep
neuromuscular blockade. Br J Anaesth 2014; 112: 498-505
2. Torensma B, Martini C, Boon M, Olofsen E, in *t Veld B, Liem RSL, Knook MTT,
Swank DJ, Dahan A. Deep neuromuscular block improves surgical conditions during
bariatric surgery and reduces postoperative pain: a randomized double blind
controlled trial. PLoS ONE 2016; 11: 20167907
Study objective
Main objective
To study the surgical conditions in patients undergoing laparoscopic renal or
prostate surgery during deep versus moderate neuromuscular block as assessed by
the Leiden Surgical Rating Scale.
Minor objectives
1. To study the hemodynamic conditions during deep versus moderate
neuromuscular block.
2. To study the nociception level during deep versus moderate neuromuscular
block.
3. To assess the effect of deep versus moderate NMB on pain, sedation and
nausea/vomiting in the recovery room (PACU).
4. To compare rating of the surgical field obtain from video images among
surgeons and anesthesiologsist.
Study design
Double-blind randomized
Study burden and risks
None to be expected
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
(i) Patients diagnosed who are will undergo an elective laparoscopic renal
surgical procedure, i.e. (donor) nephrectomy
(ii) ASA class I-III
(iii) > 18 years of age;
(iv) Ability to give oral and written informed consent.
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) Women who are or may be pregnant or are currently breast feeding;
(v) 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).
(vi) Previous retroperitoneal surgery at the site of the current surgery.
(vii) Body mass index > 35 kg/m2
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL60821.058.17 |