Researcher want to compare and evaluate the effect of sugammadex on postoperativerecovery, with a focus on the occurrence of postoperative urinary dysfunction, inpatients who have undergone regular abdominal surgery within a year of being infectedwith and treated for COVID-19.Post COVID-19 condition is a new and poorly understood clinical syndrome with potentiallysignificant and life-altering consequences. Recent studies suggest that patients who haverecovered from COVID-19 may experience autonomic dysfunction and be at risk for autonomicdysregulation/syndrome. In most patients undergoing general anesthesia, neuromuscularblockers are used, and their residual effects delay the recovery of autonomic functionafter surgery, leading to problems such as worsening bladder and bowel function.Therefore, reversal agents are used to aid in postoperative muscle recovery, withsugammadex and neostigmine being commonly used in clinical practice. While sugammadex isgenerally expected to result in faster postoperative recovery, limited reports exist onits effectiveness in patients who have recovered from COVID-19. This study aims to verifywhether sugammadex is more effective than neostigmine in aiding the recovery of bowel andpulmonary function after surgery in patients who have recovered from COVID-19.
The COVID-19 has had a huge impact on the world, infected tens of millions and killed
hundreds of thousands, and has become a threat to humanity's medical defense system.
COVID-19 was understood as an acute infection among infections, and it was expected that
there would be little or no other risk if the acute symptoms were treated. Contrary to
our expectations, however, patients with a history of infection with the coronavirus have
reported patients with sequelae lasting for more than several months. The symptoms shown
by these patients were not limited to some tissues and organs, but were distributed in
various ways throughout our body. These symptoms were defined as 'long COVID'. In
particular, among the symptoms of long COVID patients, there were patients who were
diagnosed with orthostatic hypotension, vasovagal syncope, and orthostatic tachycardia
syndrome from symptoms such as palpitations, shortness of breath, and chest pain. What
these diseases have in common is that they are autonomic nervous system diseases.
Therefore, it can be assumed that long COVID patients have damage to the function of the
autonomic nervous system due to past infections, and many studies have been conducted on
this.
The main components of general anesthesia are known to be unconsciousness, muscle
relaxation, analgesia, and reflex suppression. Among these, the reasons why muscle
relaxation is necessary in general anesthesia include ease of intubation and suppression
of unnecessary patient movements during surgery to create a suitable environment for
surgery. For muscle relaxation, anesthesiologists administer neuromuscular relaxants,
mainly non-depolarizing muscle relaxants. Neuromuscular relaxants have the role of
inhibiting neurotransmission by acting on the motor nerve endings of skeletal muscles,
because they act on nicotinic cholinergic receptors in motor nerve endings. However,
neuromuscular relaxants also act on muscarinic cholinergic receptors to inhibit
neurotransmission. Since these muscarinic cholinergic receptors are distributed in the
parasympathetic nerves of the autonomic nervous system, neuromuscular relaxants also
inhibit the autonomic nerve system controlled by the parasympathetic nerves.
Since neuromuscular relaxants are eliminated from the body by pharmacokinetics, the
function of the autonomic nervous system, which has been suppressed by using
neuromuscular relaxants, gradually recovers over time. However, if the action of a
neuromuscular relaxant remains after surgery, the patient will experience autonomic
dysfunction even after surgery, which causes considerable discomfort to the patient.
Among them, the symptoms of autonomic dysfunction related to the parasympathetic nerve
that patients mainly feel are related to the bladder and bowel. Therefore, after the
surgery, the anesthesiologist performs the process of reversing the action of the
neuromuscular relaxant when ending general anesthesia, which makes it possible to expect
the recovery of the patient's autonomic nervous system function.
There are two main mechanisms of the drugs used for reversal of nondepolarizing
neuromuscular relaxants. First, there is a drug that inhibits the action of the
neuromuscular relaxant by directly attaching to the neuromuscular relaxant, and second,
there is a drug that competitively inhibits the neuromuscular relaxant by increasing the
amount of ach in the neuromuscular junction. In the meantime, many studies have shown
that a drug with the former mechanism (sugammadex) is superior to the latter drug
(typically neostigmine) in the recovery of patients after surgery. However, there is a
lack of research on whether the same research results will be shown in long COVID
patients who have caused damage to the autonomic nervous system.
Therefore, in this study, sugammadex and neostigmine as described above are divided and
administered to approximately 300 long COVID patients in a double-blind manner, and the
degree of urinary retention is compared to prove that sugammadex is superior to
neostigmine in postoperative recovery even for long COVID patients.
Drug: Sugammadex Sodium
Sugammadex Sodium 2mg/kg when TOF >= 2, postoperative period
Other Name: Bridion
Drug: neostigmine 50µg/kg + glycopyrollate 0.01mg/kg
neostigmine 50µg/kg + glycopyrollate 0.01mg/kg when TOF >= 2, postoperative period
Other Name: neostigmine
Inclusion Criteria:
- Ages between 19 and 70 Male and Female All ethnicity Patients who are scheduled to
take non-emergency abdominal surgery under general anesthesia.
Patients who had the diagnosis of covid-19 by PCR, hospitalized, and applied O2
supplement therapy.
ASA classification ≤ 3 Patients who had Covid-19 PCR positive within 1 year Patients who
had hospitalized by Covid-19, followed by O2 therapy (nasal prong, continuous positive
airway pressure (CPAP), ventilator etc.) Patients who hospitalized more than 48 hours
after surgery. Patients who had a surgery for more than 1 hour.
Exclusion Criteria:
- Not meeting inclusion criteria Declined to participate Active Covid-19 patients with
PCR positive. Patients are under 19 or over 70 years old
Not Provided
Too Jae Min, M.D., Ph.D.
82-10-7296-0353
minware2@nate.com
Sang Min Yoon, M.D.
82-10-8805-8619
ekha00041@naver.com
Too Jae Min, M.D., Ph.D., Study Chair
Korea University Ansan Hospital