About this trial
Laparoscopic bariatric surgery has been recognized as the most effective treatment for obesity and related metabolic diseases. Because obesity patients often associated with sleep apnea syndrome or obesity hypoventilation syndrome, combined with the residual effect of muscle relaxants during the operation is easy to lead to respiratory obstruction and respiratory insufficiency, and hypoxemia and carbon dioxide retention are easy to occur after surgery, Post-extubation is prone to upper respiratory tract obstruction such as retrolingual fall, thus increase the risk of perioperative respiratory complications. Therefore, it is very important to achieve a rapid and effective antagonistic muscle relaxant effect, reduce the postoperative muscle relaxation residue, and maintain the patency of the patient's airway.
Compared with the traditional cholinesterase inhibitor neostigmine, sugammadex is a specific antagonist of novel aminosteroid muscle blockers, which rapidly reverses moderate and deep neuromuscular block by combining with rocuronium or vecuronium 1:1,without compatibility with due to its no effect on muscarinic receptors or plasma cholinesterase. The absence of cholinergic and cardiovascular effects during awakening from anesthesia would be significant benefit for patients with cardiovascular or respiratory diseases.
The pharmacological effect of sugammadex is its ability to form a tight 1:1 complex with amino steroid neuromuscular blockers, which causes a lower plasma concentration of free neuromuscular blockers and promotes the transfer of neuromuscular blockers from the peripheral compartment (including the neuromuscular junction) to the plasma gradient. A meta-analysis by Vaghiri et al showed that reversal of neuromuscular block by sugammadex accelerated postoperative recovery of intestinal peristalsis in patients undergoing colorectal surgery compared with acetylcholinesterase inhibitors. Deljou et al confirmed that reversal of neuromuscular blockade with sugammadex shortened the time to first postoperative defecation in patients compared with neostigmine / glononium bromide. The study will investigate the effect of sugammadex in patients undergoing laparoscopic bariatric surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-50 years
Body Mass Index (BMI) ≥ 40kg/m²
American Society of Anesthesiologists (ASA) grade I to III classification
NYHA cardiac function grade I - II
Disqualifiers
Patients with neuromuscular disease or respiratory system disease
Patients with severe abnormal liver and renal function
Perioperative use of drugs known to interact with rocuronium
Patients with unstable mental illness or refusal to participate
Trial design
Parallel
Treatments tested in this trial
Sugammadex
DrugWhen T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight), the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
Neostigmine
DrugWhen T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
Treatment groups
Trial outcomes
Primary outcomes
Postoperative muscle relaxation recovery
Postoperative muscle relaxation recovery, measured using the time of train-of-four stimulation (TOF) ratio ≥0.9
Secondary outcomes
Postoperative pain scores at rest and during coughing
Pain scores, measured using the Visual Analog Scale(0 points indicated no pain, a score \<4 indicated mild pain; a 4-7 score indicated moderate pain, a score \>7 points indicated severe pain, and a score of 10 indicated unbearably severe pain)
Postoperative opioid consumption
The total amount of sufentanil used in the PCA pump within the initial 48 hours postoperatively
Postoperative remedial analgesia rate
The rate of remedial analgesia 48 hours postoperatively
Postoperative arterial blood gas
PaO2 and PaCO2, measured using the blood-gas analyzer
Locations
Sponsors and contacts
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