To assess whether the implementation of a deep neuromuscular block (NMB) (PTC 1-2) combined with induction of relative hypocapnia creates optimal surgical conditions as measured by the surgeon (using the 5-point Leiden surgical rating scale) versus…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the surgical conditions in patients undergoing laparoscopic renal or
prostate surgery during low and normal arterial PCO2 levels as assessed by the
surgical rating scale.
Secondary outcome
To assess the relation between scoring of surgical conditions by the surgeon
and video assisted scoring of surgical conditions.
To study the hemodynamic conditions during low arterial CO2 concentration (3.5
kPa or 26.3 mmHg) versus normal arterial CO2 concentration (6.5-7.0 kPa or
48.8-52.5 mmHg )
To assess respiratory function, pain, nausea/vomiting postoperative following
anesthesia maintained at low or normal arterial CO2 concentration
To assess whether a deep neuromuscular block (PTC 1-2) combined with induction
of relative hypocapnia (PaCO2 3.5 kPa or 26.3 mmHg) and reversal with
sugammadex (4 mg/kg) will result in extubation within 5-min following reversal
and excellent postoperative respiratory conditions.
Background summary
surgical conditions during laparoscopy are largely determined by the level of
neuromuscular block. Deep neuromuscular block at 1-2 twitches post titanic
count has shown to provide superior surgical conditions compared to a moderate
neuromuscular block of 1-2 twitches train of four. However, despite a deep
neuromuscular block measured peripherally at the nervus ulnaris, surgical
conditions may still be suboptimal. A major factor influencing the surgical
conditions includes involuntary movements by the diaphragm. These involuntary
movements are triggered in the brainstem by local carbon dioxide levels. In
this study we intend to study the effect of variations in the arterial CO2
concentration on the surgical conditions as assessed by the surgical rating
scale
Study objective
To assess whether the implementation of a deep neuromuscular block (NMB) (PTC
1-2) combined with induction of relative hypocapnia creates optimal surgical
conditions as measured by the surgeon (using the 5-point Leiden surgical rating
scale) versus a deep neuromuscular block (PTC 1-2) combined with normocapnia.
Study design
This is a single-center randomized comparative single-blinded interventional
study
Intervention
Two patient groups, one in which the arterial CO2 concentration is controlled
to values of 3.5 kPa or 26.3 mmHg (GROUP 1; n=20), the other in which the
target is 6.5-7.0 kPa or 48.8-52.5 mmHg (GROUP 2; n=20). Variations in arterial
CO2 concentration are applied by changes in minute ventilation. All surgical
procedures will be performed by one surgeon.
Study burden and risks
After induction of anesthesia, an arterial line will be placed in one of both
radial arteries for hemodynamic monitoring and drawing of bloodsamples (12 x 2
ml = 24ml). This is a standard anesthesiological procedure and is used for
various (other) procedures.
Albinusdrees 2
Leiden 2300 RC
NL
Albinusdrees 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
(i) Patients diagnosed with renal or prostatic disease who are will undergo an elective
laparoscopic renal surgical procedure or laparoscopic prostatectomy;
(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
(viii) Chronic obstructive pulmonary disease GOLD 2-4 or a FEV1 less than 70% predicted or VC less than 70% predicted
(ix) chronic pulmonary disease with altered lung physiology (eg. sarcoidosis, cycstic fibrosis, obstructing pulmonary tumors, previous lung surgery)
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 | NL45461.058.13 |