Sugammadex is a modified gamma-cyclodextrin that is used to reverse steroidal non-depolarizing neuromuscular blocking drugs rocuronium and vecuronium. Residual neuromuscular blockade is common after surgery, with an estimated 30 to 60% incidence in the recovery room.

1. Sugammadex :
a Revolutionary Reversal in Neuromuscular
Blocking Agent (NMBA)

2. NMBA /
Muscle
Relaxant
 in anesthesia to facilitate endotracheal
intubation, assist with mechanical ventilation in
patients who have reduced lung compliance, and
treatment of Convulsion / seizure, and optimize
certain surgical conditions,
https://www.ncbi.nlm.nih.gov/books/NBK538301/

3. https://pubs.asahq.org/anesthesiology/article/138/1/13/137379/2023-American-Society-of-Anesthesiologists
Most commonly used NMBA :
Rocuronium > Vecuronium > Pancuronium > Cisatracurium > Atracurium

4. https://www.ncbi.nlm.nih.gov/books/NBK519510/figure/article-25954.image.f1/

5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4173552/

6. Sugammadex  Reversal NMBA
Enkapsulasi
Prinsip Kerja Sugammadex  membuat kompleks yang dapat larut dalam
air dengan Agen Neuromuscular Blocking (rocuronium > vecuronium) dengan rasio 1:1
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4173552/
1. saat memasuki plasma itu : Sugammadex membungkus
(enkapsulasi) aminosteroid yang bersirkulasi  menjadi
tidak aktif
2. Sugammadex mendorong disosiasi (pelepasan) aminosteroid dari
neuromuscular junction (NMJ) lalu dienkapsulasi  memungkinkan kembalinya
fungsi neuromuskuler.

11.  Postoperative nausea and vomiting (PONV) is not usually a fatal post operative complication but is
nonetheless particularly distressing
 One of the most unpleasant experiences during the postoperative period, and has significant consequences
for satisfaction, patient outcomes and costs of care

12. Guideline recommend strategies to further
reduction risk of PONV

13. Sugammadex & PONV

14. Sugammadex mampu membuat pengosongan ruang operasi
lebih cepat dan dapat diprediksi
aOR discharge times:
neostigmine = 13.87 ±
11.43 minutes;
sugammadex = 9.15 ±
4.28 minutes.1
CI = confidence
interval; MD = mean
difference; NMB =
neuromuscular
block; OR =
operating room;
PACU = post-
anesthesia care unit.
P=0.005
Reduction
with
sugammadex:
4.72 minutes
Suatu meta-analisis dari 6 studi yang membandingkan pasien usai diberikan sugammadex dan neostigmin.
Sugammadex diasosiasikan dengan keluarnya pasien dari ruang operasi lebih cepat dari:
– Ruang Operasike post-anesthesiacareunit (PACU) (MD = 22.14 menit, 95% CI [14.62, 29.67], P< 0.00001)
– PACU ke rawat inap (MD = 16.95 menit, 95% CI [0.23, 33.67], P=0.0469)
13.87
9.15
2
0
4
8
6
10
14
12
Waktu rata2 pengosongan OR dengan neostigmine
dan sugammadex4
16
Time
(minutes)
Discharge times
Neostigmine Sugammadex
Reduksi
dengan
sugammadex:
4.72 menit
• Suatu studi acak, terkontrol di Belgia yang melibatkan 100
perempuan yang menjalani laparoskopi histerektomi dari
February 2011 hingga May 2012, ditemukan bahwa
sugammadex mengurangi waktu pengosongan OR sebanyak
rata2 4.72 menit dibandingkan neostigmine (P-0.005).
• Studi ini menunjukan bahwa pengosongan ruang operasi
menjadi lebih singkat dengan variable yang sedikit setelah
pemberian sugammadex dibandingkan neostigmine.
Pengosongan ruang operasi yang lebih singkat juga diamati
dengan membandingkan pasien sugammadex pada NMB level
deep block terhadap pasien neostigmine di level NMB moderate
atau pada level yang lebih rendah
P=0.005
Putz L et al. J Clin Anesth. 2016;35:107– 113

15. Sugammadex dapat meningkatkan jumlah pelaksanaan
operasi serta menurunkan biaya
OR = operating room.
• Waktu yang dihemat dengan sugammadex bukan hanya berdampak pada produktivitas
tapi juga mengurangi biaya yang diasosiasikan dengan OR occupancy.
• Suatu studi restrospektif menganalisa data dari tahun 2009 hingga 2013 pada 99 pasien obesitas yang melalui operasi elektif
bariatric laparoskopi pada suatu institusi di Italia. Pasien mendapatkan rocuronium dilanjutkan dengan Sugammadex (n=50) atau
rocuronium/cisatracurium dilanjutkan dengan neostigmine (n=49). Studi mendapatkan bahwa sugammadex mengurangi durasi
penuhnya ruang operasi (OR occupancy) sehingga dapat mengurangi biaya dan meningkatkan alur kerja
Penambahan operasi dapat dilakukan pada penggunaan sugammadex
dibandingkan neostigmin pada tindakan laparoscopicsleevegastrectomies
Pada waktu yang
samadimana selesai
dilakukannya 50
prosedur bariatric
dengan neostigmine,
12operasi tambahan
dapat dilakukan
dengan waktu yang
lebih hemat dengan
sugammadex.6
Carron M et al.J Clin Anesth. 2017;39:38–44
Sugammadex

16. Model Discrete event simulation (DES) menunjukan bahwa sugammadex dapat mengurangi kelebihan
waktu kerja dari staff di ruang operasi dan meningkatkan efisiensi ruang operasi (OR)
aFull recovery defined
as train-of-four (TOF)
ratio of ≥0.9.
DES = discrete event
simulation; NMB =
neuromuscular block;
OR = operating
room; TOF = train-
of-four.
Satu analisis eksplorasi dari model ini juga menemukan bahwa, saat melakukan reversal
deep NMB, sugammadex dapat menghemat 30 menit waktu di ruang operasi per prosedur
pe bulan dibandingkan dengan neostigmine/glycopyrrolate, yang dapat menghasilkan:
– 62 % reduksi waktu lembur dari staff yang dibayarkan
– Jumlah prosedur yang dibatalkan akibat waktu di ruang operasi yang tidak cukup berkurang dari
1.2 menjadi 0.4
 Suatu model discrete event simulation membandingkan ruang operasi yang menggunakan sugammadex sebagai
reversal neuromuscular block (NMB) dengan ruang operasi yang menggunakan neostigmine selama periode 1bulan di suatu rumah sakit di Kanada
 Model ini menilai dampak dari sugammadex pada efisiensi ruang operasi tergantung pada persentase pasien sugammadex
yang sepenuhnya pulih dari deep NMB.
– Untuk pasien yang leve deep blocknya dipertahankan hingga akhir prosedur, sugammadex terlihat memperbaiki efisiensi ruang operasi
dan juga mengurangi komplikasi residual blokade.
Perbandingan antara sugammadex dan neostigmine pada efisiensi ruang operasi selama satu bulan pada reversal moderate NMB
Neostigmine
sugammadex
50% of Patients
verified to have full
NMB recovery
sugammadex
100% of Patients
verified to have full
NMB recovery
Persentase hari dimana semua prosedur
diselesaikan pada hitungan hari OR normal
40.6% 58.0% 72.7%
Prosedur yang dibatalkan karena kurangnya
waktu di ruang operasi
3.5 1.9 1.1
Waktu lembur staff yang dibayarkan 57.8 38.9 24.3
InsingaRP et al. BMC Anesthesiol. 2016:1– 12.

17. Sugammadex mengurangi jumlah komplikasi klinis serta biaya
yang menyertai
AE = adverse event.
Cost of complicationswith sugammadex, neostigmine,
and spontaneous recovery strategies
• Komplikasi operasi secara signifikan memberikan dampak
pada pengeluaran rumah sakit dan meningkatkan biaya
operasi sebesar $17,804.
• Sugammadex menunjukan penurunan 70% biaya yang
diasosiasikan dengan komplikasi, dibandingkan dengan
neostigmine.
– Suatu analisis di cost-effectiveness di tahun 2010
dilakukan dengan menggunakan model decision tree
yang mempertimbangkan biaya terapi dan komplikasi
termasuk hipoksia ringan, hipoksia berat dan
pneumonia.
– Frekuensi residual block dan efek samping
diperhitungkan lewat study meta analisis sebelumnya.
Suatu analisis univariate sensitivitas dilakukan untuk
mengecek kekuatan dari model ini.
Bahkan ketika biaya pengobatan diperhitungkan, biaya total grup dengan
sugammadex tetap lebih rendah dari biaya total grup dengan neostigmine dan grup
dengan pemulihan spontan.
Sugammadex
Ozdemir Oet al.International Societyfor Pharmacoeconomics andOutcomesResearch(ISPOR)Annual European Congress.November 6–9, 2010. Poster PND22.
Fu SJet al. Minim InvasiveSurg. 2016;2016:1– 7

18. KEY POINTS
 Sugammadex is the first reversal agent to encapsulate aminosteroid
neuromuscular blocking agents, reversing all depths of rocuronium and
vecuronium neuromuscular blockade.
 Sugammadex is used in high risk patients surgery as Reversal agent of
Neuromuscular Blocking Agent (NMBA)
 Sugammadex is more effective at reversing deep paralysis than neostigmine
 Sugammadex is recommended to reduce POPC (Post-operative Pulmonary
Complication) and PONV (Post-operative Nausea Vomiting)
 Sugammadex can contribute to the hospital management system in terms of
anesthesiology, surgery, and operating room health care system
https://resources.wfsahq.org/atotw/an-overview-of-sugammadex/

19. FDA dosing recommendations
for adults and children
https://www.openanesthesia.org/keywords/reversal-of-neuromuscular-blockade-sugammadex/

20. SOGOMA(Sugammadex) is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent
Indications. Reversal of neuromuscular blockade induced by rocuronium or vecuronium
Dosage and Administration. Sugammadex should only be administered by, or under the supervision of an anesthetist. The use of an appropriate neuromuscular
monitoring technique is recommended to monitor the recovery of neuromuscular blockade. The recommended dose of sugammadex depends on the level of
neuromuscular blockade to be reversed.
Deep Block: 4 mg/kg body weight; Moderate Block: 2 mg/kg body weight. Immediate reversal: 16mg/kg sugammadex.
Drug Interactions. Interactions potentially affecting the efficacy of sugammadex: Toremifene, Intravenous administration of fusidic acid. Interactions potentially
affecting the efficacy of other medicinal products: Hormonal contraceptives, The interaction between 4 mg/kg sugammadex and a progestogen was predicted to
lead to a decrease in progestogen exposure
Information on Use in Specific Populations. Renal Impairment: The use of sugammadex in patients with severe renal impairment (including patients requiring
dialysis (CrCl < 30 ml/min)) is not recommended. Elderly patients:Even though the recovery times in elderly tend to be slower, the same dose recommendation as
for adults should be followed. Obese patients: In obese patients, the dose of sugammadex should be based on actual body weight. The same dose
recommendations as for adults should be followed. Hepatic impairment: For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no
dose adjustments are required. Children and adolescents:For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents
(2-17 years) 2 mg/kg sugammadex is recommended. Term newborn infants and infants:There is only limited experience with the use of sugammadex in infants
(30 days to 2 years), and term newborn infants (less than 30 days) have not been studied. The use of sugammadex in term newborn infants and infants is therefore
not recommended until further data become available.
Adverse Events. Airway Complication of Anesthesia: bucking against the endotracheal tube, coughing, mild bucking, arousal reaction during surgery, coughing
during the anesthetic procedure or during surgery, or contra breath. Anesthetic complication: movement of a limb or the body or coughing during the anesthetic
procedure or during surgery, grimacing, or suckling on the endotracheal tube. Procedural Complication: coughing, tachycardia, bradycardia, movement, and increase in
heart rate. Recurrence of neuromuscular blockade : sub optimal dose.
Drug hypersensitivity reactions: Symptoms associated with these reactions can include: flushing, urticaria erythematous rash, (severe) hypotension, tachycardia,
swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events. Severe hypersensitivity reactions can be fatal.
Precautions. Re-administration of rocuronium or vecuronium after routine reversal (up to 4 mg/kg Sugammadex):Minimum waiting time 5 min, NMBA and dose to be
Administered 1.2 mg/kg rocuronium, ):Minimum waiting time 4 hours, NMBA and dose to be Administered 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Marked bradycardia: In rare instances, marked bradycardia has been observed within minutes after the administration of Sugammadex for reversal of neuromuscular
blockade. Patients with bronchospasm: Patient with severe systemic disease (ASA 3 and 4)
SOGOMA Product Information BPOM Approved. 2023

21. First Mitu Product
Sebagai agen reversal dari neuromuscular blockade yang diinduksi oleh
rocuronium atau vecuronium

22. https://e-katalog.lkpp.go.id/katalog/produk/detail/55616024?lang=id&type=province

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