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About BRIDION
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About BRIDION® (sugammadex)

Prescribing Information

WHEN
CONTROL
MATTERSWHEN CONTROL MATTERS

Find out about advances in anaesthesia and enhanced recovery, as well as how BRIDION (sugammadex) could help obtain optimal conditions throughout surgical procedures and help improve outcomes.

BRIDION is for the reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.1

For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.1

Benefits and Outcomes

BRIDION provides predictable, complete*, and rapid** reversal, and allows deep neuromuscular block to be maintained throughout the surgical procedure.


 INDUCTION ▸ SURGERY ▸ RECOVERY ▸

Induction with
ESMERON® (rocuronium bromide)		 Maintenance of deep NMB Reversal of deep NMB with BRIDION
What are the clinical benefits?
  • Fast onset of action2
  • Suitability for rapid sequence induction2
  • Excellent intubation conditions (Intubating conditions were rated as excellent in >70% of cases in both routine anaesthesia and rapid sequence induction)2
  • Flexible dosing regimen2
  • Maintain stillness throughout the procedure4
  • Enhanced visual field and may improve surgical access5
  • May permit the use of lower insufflation pressure5
  • Predictable and rapid** reversal to help reduce recovery time8
  • Complete* reversal to reduce risk of complications9
What are the outcomes?
  • Reduction in arterial hypotension or bradycardia requiring treatment3
  • Less postoperative and shoulder tip pain following low pressure than standard pressure7
  • Improved quality of life following low pressure7
  • Elimination of residual blockade9
  • Reduction of time in PACU (in laparoscopic bariatric surgery patients)10
  • Less need for pain analgesia than neostigmine (in laparoscopic bariatric surgery patients)10
  • Potential benefits to overall productivity and resource utilisation

*Reversal was considered complete at a Train-of-Four (TOF) ratio of 0.9

**Sugammadex reversed patients from reappearance of T2 in 1.4 minutes from moderate blockade (n=47)12 and reversed patients from 1 to 2 PTCs in 2.7 minutes from deep blockade (n=37)8

Induction with rocuronium bromide
  • Nearly all patients achieved adequate intubation conditions within 60 seconds2
  • 80% of intubations were rated excellent2
  • Rocuronium bromide had a similar train-of-four (TOF) fade and a fast onset of action when compared with equipotent doses of other non-depolarizing NMBAs11

Onset times of NMBAS

Onset times of NMBAS

*p<0.01 vs mivacurium and vecuronium; **p<0.01 versus atracurium and rocuronium; patients excluded for protocol violations (vecuronium n=2; cisatracurium=1).

Adapted from Carroll et al, 1998 11

90 patients aged 18-65 and classified as grade 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification System were included in the study. Anaesthesia was induced with fentanyl 1 to 5 µg/kg and propofol 1.5 to 2.5 mg/kg followed by 66% nitrous oxide in oxygen and a propofol infusion. The ulnar nerve was stimulated at the wrist with supramaximal stimuli to 0.2 ms duration, in a TOF mode at 2 Hz every 12 seconds. Following stabilisation of control responses, patients were randomly allocated (using a computer generated list) to receive cisatracurium 0.05 (n=14) or 0.1 mg/kg (n=14), atracurium 0.5 mg/kg (n=15), mivacurium 0.15 mg/kg (n=15), vecuronium 0.08 mg/kg (n=13), or rocuronium 0.6 mg/kg (n=15) over 5 seconds into a fast-flowing infusion. TOF fade characteristics and onset of action were recorded.11

Maintenance of deep block

Maintaining deep block throughout the procedure can help to optimise surgical conditions. Indeed, deep block has been shown to provide less variation in the quality of surgical conditions compared to moderate block, with 99% of scores rated as good or optimal.6†

What do optimal surgical conditions mean for a surgeon?

Reducing the depth of NMB can affect the quality of surgical conditions. Maintaining deep block, however, can ensure optimal surgical conditions are met right up until the end of the procedure.

  • Maintained stillness throughout procedure4
  • Enhanced visual field and improved surgical access5
  • Lowered CO2 insufflation pressure5
  • Lower peritoneal pressure results in improved patient outcomes7

 

Mean intensity of postoperative pain assessed by the VAS scale, significantly reduced by 22.2% less (p<0.005)

 

Shoulder tip pain more than halved from 24% to 11 (p=0.03)

There was also:

QOL scores for physical domain significantly improved from 78% to 89% (p<0.01)

†24 patients undergoing laparoscopic prostatectomy or nephrectomy were randomised to receive moderate NMB (TOF 1-2) using atracurium/mivacurium combination vs deep NMB (PTC 1-2) using high dose rocuronium. Randomisation was performed using a computer generated randomisation code. NMB was reversed with neostigmine (moderate NMB, n=12), or sugammadex (deep NMB, n=12). For all outcomes, one surgeon scored the quality of surgical conditions from 1 (extremely poor) to 5 (optimal). Video images were obtained and 12 anaesthetists rated a random selection of images. All participants were blinded to treatment.7 The primary endpoint of the study was the influence of the depth of the NMB on the surgical rating scale.
This study aimed to investigate the advantages and disadvantages of low pressure (LP 7 mmHg) in comparison to standard pressure (SP 12 mmHg) pneumoperitoneum in a prospective randomised clinical trial. 148 consecutive patients qualified for laparoscopic cholecystectomy (LC) due to uncomplicated symptomatic gallstones were randomised to either SPLC or LPLC. All the procedures were performed by the same experienced team of surgeons. The statistical analysis included sex, mean age, body mass index, ASA (American Society of Anesthesiology) grade, operative time, complication rate, conversion rate, postoperative pain assessed by the Visual Analogue Scale of Pain (VAS) including the incidence of shoulder-tip pain, postoperative hospital stay, recovery time, and the quality of life (QOL) within 7 days following the operation. p<0.05 was considered as indicative of significance.7

Reversal of deep NMB with BRIDION

Avoiding residual block at the end of the surgical procedure is important as this could affect patient recovery times in the post-anaesthesia care unit (PACU).13

BRIDION is a selective relaxant binding agent that reverses the deep NMB achieved with ESMERON.14

BRIDION can be used for all levels of muscle relaxation to provide:

  • Predictable reversal
  • Complete* recovery
  • Rapid** action

*Reversal was considered complete at a Train-of-Four (TOF) ratio of 0.9

**Sugammadex reversed patients from reappearance of T2 in 1.4 minutes from moderate blockade (n=47)11 and reversed patients from 1 to 2 PTCs in 2.7 minutes from deep blockade (n=37)8

Rapid action and predictable reversal

The rapid action and predictable reversal that can be achieved with BRIDION can be illustrated by data from two randomised controlled trials:

A higher percentage of patients achieved complete recovery after 5 minutes of BRIDION administration when compared to neostigmine.8,12

The median time (mins) to recovery from NMB

Based on data from 37 patients treated with BRIDION and 37 treated with neostigmine

Adapted from Jones et al, 20088

Randomised controlled trial comparing BRIDION (4 mg/kg) and neostigmine (70 μg/kg) plus glycopyrrolate (14 μg/kg) for recovery from deep rocuronium-induced NMB in 74 adult surgery patients. The primary endpoint was the median time to recovery from deep NMB8

Based on data from 48 patients treated with BRIDION and 48 treated with neostigmine

Adapted from Blobner et al, 201012

Randomised controlled trial comparing BRIDION (2 mg/kg) and neostigmine (50 μg/kg) plus glycopyrrolate (10 μg/kg) for recovery from moderate rocuronium-induced NMB in 98 adult surgery patients. The primary endpoint was the median time to recovery from moderate NMB12

Percentage of patients showing a complete* recovery after 5 minutes

Adapted from Jones et al, 20088

Please refer to study description above.

Adapted from Blobner et al, 201012

Please refer to study description above.

*Reversal was considered complete at a Train-of-Four (TOF) ratio of 0.9

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References

  1. BRIDION Summary of Product Characteristics.
  2. ESMERON Summary of Product Characteristics.
  3. Combes X, Andriamifidy L, Dufresne E, et al. Comparison of two induction regimens using or not using muscle relaxant: impact on postoperative upper airway discomfort. Br J Anaesth. 2007;99(2):276–81. Double blind study, 300 adults requiring intubation for peripheral surgery, given rocuronium or no NMB. Primary end-point: rate of post-intubation symptoms after extubation.
  4. Welliver M, McDonough J, Kalynych N, Redfern R. Discovery, development, and clinical application of sugammadex sodium, a selective relaxant binding agent. Drug Des Devel Ther. 2009;2:49–59
  5. Geldner G, Lang C, Hoffmann W, et al. A randomised controlled trial comparing sugammadex and neostigmine at different depths of neuromuscular blockade in patients undergoing laparoscopic surgery. Anaesthesia. 2012;67(9):991–8.
  6. Martini CH, Boon M, Bevers RF, et al. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014;112(3):498–505. 24 adults undergoing laparoscopic prostatectomy or nephrectomy randomised to moderate (TOF 1-2) vs deep NMB (PTC 1-2). One surgeon scored the quality of surgical conditions and was blinded to treatment.
  7. Barczyński M, Herman RM. A prospective randomized trial on comparison of low-pressure (LP) and standard-pressure (SP) pneumoperitoneum for laparoscopic cholecystectomy. Surg Endosc. 2003;17(4):533–8. Prospective, randomised study, n= 148 adults, laparoscopic cholecystectomy, randomized to either standard pressure (12 mm Hg) or low pressure (7 mmHg). Postop pain assessed by the Visual Analogue Scale (VAS) (shoulder-tip pain, postoperative hospital stay, recovery time, and quality of life (QOL) within 7 days postop).
  8. Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008;109(5):816–24. Phase 3 study, n=74 adults, randomised controlled study comparing BRIDION (4 mg/kg) and neostigmine (70μg/kg) plus glycopyrrolate (14μg/kg) for recovery from deep rocuronium-induced NMB.
  9. Brueckmann B, Sasaki N1, Grobara P, et al. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015;115(5):743–51. Randomised assessor-blinded trial, n=154, reversal of rocuronium-induced NMB with sugammadex (2 or 4 mg/kg) or usual care (neostigmine / glycopyrrolate, dosing per usual care practice). Primary endpoint: presence of residual NMB at PACU admission defined as a TOF<0.9.
  10. Castro DS, Leão P, Borges S, et al. Sugammadex reduces postoperative pain after laparoscopic bariatric surgery: a randomized trial. Surg Laparosc Endosc Percutan Tech. 2014;24(5):420–3. 88 morbidly obese patients undergoing laparoscopic bariatric surgery under GA with NMB, randomly assigned to sugammadex (2mg/kg CBW) or neostigmine (0.05mg/kg together with atropine 0.02 mg/kg CBW). Primary endpoint: pain between 2 groups compared using VAS in PACU. Analgesia maintenance: remifentanil (0.15 to 0.30 mg/kg CBW). Postop analgesia: 1 g acetaminophen, 2 g metamizole, 200 mg tramadol, 30mg ketorolac. Analgesic rescue therapy in the PACU: morphine and other opioids.
  11. Carroll MT, Mirakhur RK, Lowry DW, et al. Neuromuscular blocking effects and train-of-four fade with cisatracurium: comparison with other nondepolarising relaxants. Anaesthesia. 1998;53(12):1169–73.
  12. Blobner M, Eriksson LI, Scholz J, et al. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia; results of a randomised, controlled trial. Eur J Anaesthesiol. 2010;27(10):87481.
  13. Butterly A, Bittner EA, George E, et al. Postoperative residual curanization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010;105(3):304-9.

Supporting documentation

BRIDION
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

ESMERON
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-XBR-00192 | Date of Preparation: May 2020