Obesity Clinical Trial
Official title:
Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Patients Undergoing Laparoscopic Gastric Bypass Surgery
The purpose of this study is to investigate if a deep neuromuscular block with a continuous
infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with
reversal of neuromuscular blockade with sugammadex results in improved surgical conditions
for the surgeon and/or improved post-operative respiratory function for the patients as
compared to a standard technique with an intubation dose of rocuronium and top-ups as needed
to maintain a neuromuscular blockade with a TOF count of 1-2 and reversal of neuromuscular
blockade with neostigmine/glycopyrrolate.
Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium
and reversal with sugammadex or neostigmine/glycopyrolate on cerebral tissue oxygenation.
Laparoscopic bariatric surgery poses special demands on the anaesthesiologist as well as the
surgeon. The surgeon requires good visualisation of the operative field while the
anaesthesiologist is concerned with adequate postoperative respiratory function in these
morbidly obese patients. With the advent of advanced laparoscopic techniques the time span
between adequate neuromuscular blockade (NMB) and adequate postoperative recovery of
respiratory muscle function is growing ever shorter with an increasing risk of postoperative
residual NMB.
Even minimal postoperative residual NMB with a train of four ratio (TOF) of 0.8 is
associated with impaired respiratory function as witnessed in reductions of forced
expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) in healthy volunteers.
Moreover, a TOF < 0.7 correlates with increased postoperative respiratory complications due
to the inability to swallow normally leading to aspiration, atelectasis and pneumonia.
However, neuromuscular blocking agents not only impair respiratory function due to skeletal
muscle relaxation. Also the body's response to hypoxia is impeded due to carotid body
chemoreceptor suppression. Worryingly, reversal of NMB with neostigmine can lead to
respiratory complications such as bronchospasm and even induce neuromuscular transmission
failure in patients who already recovered from NMB.
Obese patients are at even greater risk for postoperative respiratory complications. In a
recent study after bariatric surgery, 100% of patients had at least one hypoxic event
(oxygen saturation <90% more then 30seconds). Restrictive ventilatory defects are clearly
associated with body mass index (BMI) and obesity hypoventilation syndrome. Since
respiratory failure is responsible for 11.8% of mortalities after bariatric surgery, optimal
respiratory care for these patients is primordial. Optimal reversal of NMB plays an
important role herein. With the advent of Sugammadex, a cyclodextrin molecule that
encapsulates and inactivates rocuronium and vecuronium, rapid and dose-dependent reversal of
profound NMB by high dose rocuronium is possible without the risk of impaired upper airway
dilator muscle activity when given after recovery from NMB.
Furthermore, little is known about the cerebral tissue oxygen saturation (SctO2) in these
morbidly obese patients during laparoscopic gastric bypass surgery. Since the unexpected
finding that NMB influences hypoxic ventilatory response, more research is needed into the
effect of neuromuscular blockers and their reversing agents on cerebral oxygenation. Using
near infrared spectroscopy (Fore-sight®) technology absolute brain tissue oxygenation can be
quantified to study these effects.
In this study we wish to investigate if a deep neuromuscular block with a continuous
infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with
reversal of NMB with sugammadex results in:
i. Improved surgical conditions for the surgeon ii. Improved post-operative respiratory
function for the patients
as compared to a standard technique with an intubation dose of rocuronium and top-ups as
needed to maintain a NMB with a TOF count of 1-2 and reversal of NMB with
neostigmine/glycopyrrolate.
Furthermore, we wish to investigate the effect of pneumoperitoneum, and NMB with rocuronium
and reversal with Sugammadex or neostigmine/glycopyrrolate on cerebral tissue oxygenation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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