Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery (NCT02812186) | Clinical Trial Compass
CompletedPhase 4
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
United States79 participantsStarted 2016-12-27
Plain-language summary
This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.
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:
* Each participant must be willing and able to provide written informed consent for the study.
* Each participant must be American Society of Anesthesiologists (ASA) class I, II or III.
* Each participant must be scheduled for elective laparoscopic surgery (this includes robotic laparoscopic surgery).
* Expected surgical duration of 60 min or longer
Exclusion Criteria:
* Inability to give informed oral or written consent
* Known or suspected neuromuscular disorders impairing neuromuscular function;
* True allergies as defined as hypotension, bronchospasm, or anaphylaxis to muscle relaxants, anesthetics or opioids
* A history (patient or family) of malignant hyperthermia
* A contraindication for neostigmine administration
* Renal insufficiency, as defined by serum creatinine levels at 2.5 fold the normal level
* Body mass index \>40 kg/m\^2
* Significant respiratory disease.
* Planned postoperative mechanical ventilation
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.
What they're measuring
1
Peak Airway Pressures
Timeframe: Intra-operative, from intubation time to extubation time