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Effect of deep neuromuscular block and variations in arterial PCO2 on the surgical rating scale, extubation conditions and postoperative conditions following reversal with sugammadex

Phase 4
Completed
Conditions
niercelcarcinoom
prostaatcarcinoom
10027655
10038365
Registration Number
NL-OMON38910
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To study the surgical conditions in patients undergoing laparoscopic renal or<br /><br>prostate surgery during low and normal arterial PCO2 levels as assessed by the<br /><br>surgical rating scale.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>To assess the relation between scoring of surgical conditions by the surgeon<br /><br>and video assisted scoring of surgical conditions.<br /><br>To study the hemodynamic conditions during low arterial CO2 concentration (3.5<br /><br>kPa or 26.3 mmHg) versus normal arterial CO2 concentration (6.5-7.0 kPa or<br /><br>48.8-52.5 mmHg )<br /><br>To assess respiratory function, pain, nausea/vomiting postoperative following<br /><br>anesthesia maintained at low or normal arterial CO2 concentration<br /><br>To assess whether a deep neuromuscular block (PTC 1-2) combined with induction<br /><br>of relative hypocapnia (PaCO2 3.5 kPa or 26.3 mmHg) and reversal with<br /><br>sugammadex (4 mg/kg) will result in extubation within 5-min following reversal<br /><br>and excellent postoperative respiratory conditions.</p><br>
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