Sugammadex on Laparoscopic Bariatric Surgery

NCT06678451 | Not Yet Recruiting

• 1 other identifier: YXLL-2024-195
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Laparoscopic Bariatric Surgery; Sugammadex

Outcome Measures

Primary Outcomes (1)

• Postoperative muscle relaxation recovery

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

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

Secondary Outcomes (8)

• Postoperative pain scores at rest and during coughing

  1, 6, 12, 24 and 48 hours after surgery

• Postoperative opioid consumption

  48 hours after surgery

• Postoperative remedial analgesia rate

  48 hours after surgery

• Postoperative arterial blood gas

  12, 24 and 48 hours after surgery

• Postoperative pulmonary function

  12, 24 and 48 hours after surgery

Study Arms (2)

Sugammadex group

EXPERIMENTAL

When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight)

Drug: Sugammadex

Neostigmine group

ACTIVE COMPARATOR

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

Drug: Neostigmine

Interventions

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).

Sugammadex group

Neostigmine DRUG

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

Neostigmine group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Jian-Wen Zhang, MD

  Shanxi Bethune Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Wen Zhang, MD

CONTACT

+86 13994299284; zjw030001@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11