Sugammadex on Laparoscopic Bariatric Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanxi Bethune Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sugammadex

    Drug

    When 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

    Drug

    When T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sugammadex groupExperimental treatment 1 intervention
Group B: Neostigmine groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative muscle relaxation recovery

Postoperative muscle relaxation recovery, measured using the time of train-of-four stimulation (TOF) ratio ≥0.9

Time frame
After injection of muscle relaxation antagonist, an average of 30 minutes

Secondary outcomes

1

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)

Time frame
1, 6, 12, 24 and 48 hours after surgery
2

Postoperative opioid consumption

The total amount of sufentanil used in the PCA pump within the initial 48 hours postoperatively

Time frame
48 hours after surgery
3

Postoperative remedial analgesia rate

The rate of remedial analgesia 48 hours postoperatively

Time frame
48 hours after surgery
4

Postoperative arterial blood gas

PaO2 and PaCO2, measured using the blood-gas analyzer

Time frame
12, 24 and 48 hours after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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