Effect of Neuromuscular Block and Arterial PCO2 on Surgical Rating Scale (SRS), Following Reversa… (NCT01968447) | Clinical Trial Compass
CompletedNot Applicable
Effect of Neuromuscular Block and Arterial PCO2 on Surgical Rating Scale (SRS), Following Reversal With Sugammadex
Netherlands40 participantsStarted 2014-02
Plain-language summary
The purpose of this study is to study the effect of variations in the arterial CO2 concentration during deep neuromuscular block on the surgical conditions as assessed by the surgical rating scale
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.