Major Abdominal Surgery Clinical Trial
Official title:
Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery - A Randomized Controlled Trial
Pulmonary complications are relatively frequent after surgery, and can be associated with an
increase in morbidity and mortality. Although there are several causative mechanisms that
can lead to postoperative pulmonary complications, alterations in the shape and motion of
the chest wall are of primary importance.
In the investigator´s institution the incidence of postoperatory hypoxemia defined as
pO2/FiO2 <300 is over 20% for patients after major abdominal surgery.
Observational and randomized clinical trials have demonstrated that incomplete neuromuscular
recovery during the early postoperative period may result in acute respiratory events
(hypoxemia and airway obstruction) and an increased risk of postoperative pulmonary
complications.
A recent study in laparoscopic bariatric surgery showed that patients in which neuromuscular
block reversal was done with sugammadex had less chest X-ray pathological changes than those
from an historical cohort reversed with neostigmine.
The hypothesis is that differences in pulmonary complications, as atelectasis and hypoxemia,
between patients reverted with sugammadex or neostigmine may be more apparent with more
sensitive techniques like spirometry or lung ultrasound when they exist.
Lung ultrasound (LUS) has demonstrated a sensitivity of 90% and a specificity of 98%, to
detect alveolar consolidation in critical ill patients while chest radiography data are
known to be imprecise.The investigator would like to explore the utility of LUS in
postsurgical patients and the relationship between degree of hypoxemia and consolidation
area.
Objectives:
1. Primary: Forced vital capacity decreases after surgery. This reduction may be relieved
in the absence of residual neuromuscular block. Objective is to assess differences
after reversal with neostigmine versus sugammadex in:
• Forced vital capacity (FVC)
2. Secondary objectives: To assess differences after reversal with neostigmine versus
sugammadex in:
- Atelectasis size determined by lung ultrasound (Plannimetry)
- pO2/FiO2 <300 1 hour after surgery
- Explore the accuracy of lung ultrasound (LUS) to diagnosis postoperative
atelectasis and its correlation with chest Xray, FVC and pO2/FiO2.
Hypotheses:
1. Sugammadex NMB reversal results in a lower reduction of forced vital capacity (FVC) as
compared to NMB reversal with neostigmine.
2. Atelectasis is common after major surgery. Size of atelectasis determined by lung
ultrasound planimetry is lower one hour after sugammadex reversal as compared to the
neostigmine group.
3. The incidence of post-surgical hypoxemia is lower in the sugammadex group as compared
to the neostigmine group (Hypoxemia defined as pO2/FiO2 less than 300 is expected in
20% of patients after major abdominal surgery).
4. Lung ultrasound has a better capacity to detect alveolar consolidation than Chest Xray
after major surgery.
5. Atelectasis size determine by planimetry has a good correlation with pO2/FiO2 and
decrease of FVC after surgery
n/a
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