Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
Completed · Phase 4
Conditions studied: Cholecystitis, Endometriosis, Bowel Obstruction, Fibroids, Prostate Cancer, Chronic Kidney Disease, Uterine Prolapse
In brief
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.
Key facts
- Study ID
- NCT02812186
- Run by
- Stony Brook University
- People needed
- 79
- Starts
- 2016-12-27
- Expected to finish
- 2019-02-06
- Last updated by the study team
- 2020-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stony Brook University Hospital — Stony Brook, New York, United States
Full record on ClinicalTrials.gov
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