Is there a significant difference in the recovery of patients using sugammadex vs glycopyrrolate/neostigmine for the reversal of paralytics?

Comment by InpharmD Researcher

Although sugammadex is preferred due to rapid and predictable blocking while having lower adverse event risk, it is only effective for nondepolarizing steroidal NMBAs (e.g., rocuronium and vecuronium). Neostigmine can potentially reverse any of the non-depolarizing agents, including benzylisoquinolinium like atracurium and cisatracurium. Pharmacokinetic studies have observed a delayed clearance of the rocuronium-sugammadex complex in renally impaired patients, but it does not seem to affect efficacy possibly due to its low dissociation rate.

Background

A 2020 meta-analysis aimed to evaluate the clinical efficacy and safety of sugammadex compared to neostigmine or placebo for the reversal of rocuronium-induced neuromuscular blockade (NMB) in adult patients. A total of 22 studies were evaluated to quantify the mean difference in train-of-four (TOF) recovery time to at least 90% of complete reversal. Sugammadex was found to lead to significantly faster recovery time from two of four twitches (T2) to TOFR > 0.9 recovery of twitch height compared to neostigmine (mean difference 11.7 minutes; 95% confidence interval [CI], -15.6 to -7.8 minutes; p<0.0001). Reversal with sugammadex compared with neostigmine resulted in less anesthesia time (mean difference -18.6 minutes, 95% CI, -37.3 to 0.2 min, p= 0.056) and less post-anesthesia recovery unit (PACU) time (mean difference of -12.0 min; 95% CI, -24.7 to 0.6 minutes, p= 0.063); however, the differences were not statistically significant. Patients receiving sugammadex were significantly less likely to experience bradycardia (odds ratio [OR] 0.22; 95% CI, 0.1 to 0.5; p= 0.0003) and postoperative nausea and vomiting (OR 0.64; 95% CI, 0.46 to 0.87; p= 0.0065) compared to neostigmine patients. Overall, sugammadex leads to a faster recovery time based on the TOFR and appears better tolerated than neostigmine. [1]

A 2010 systematic review including three randomized controlled trials (RCTs) compared sugammadex with neostigmine/glycopyrrolate for the reversal of moderate or profound NMB produced by rocuronium or vecuronium. Methods of stimulation included post-tetanic count (PTC) and TOF stimulation. It was shown that recovery from moderate block had significantly faster recovery times after rocuronium or vecuronium with sugammadex versus neostigmine/glycopyrrolate. Additionally, a significant difference in moderate block recovery times was reported between rocuronium with sugammadex compared with cisatracurium with neostigmine/glycopyrrolate. There were similar trends for recovery from moderate block to a TOFR= 0.8 and 0.7 (p<0.00001). The authors suggested that sugammadex produces a substantially faster and more predictable recovery from rocuronium- or vecuronium-induced moderate NMB than neostigmine/glycopyrrolate. However, since the number of studies was limited, its clinical relevancy in practice and cost-effectiveness remain uncertain. Additionally, the clinical trials of sugammadex were not sufficiently powered to evaluate the rates of significant adverse events (AEs). Overall, the authors concluded that there are potential benefits of sugammadex in increased patient safety and predictability in NMB recovery. [2]

A 2021 meta-analysis (N= 386; 7 trials) evaluated the efficacy and safety of sugammadex versus neostigmine in the reversal of NMB in morbidly obese (MO) patients undergoing bariatric surgery. Sugammadex resulted in a significantly reduced time of reversal of moderate NMB-to-TOF ratio >0.9 compared to neostigmine (mean difference −14.52; 95% CI, −20.08 to −8.96; p<0.00001). Moreover, the number of patients who had composite adverse events was significantly lower with sugammadex compared to neostigmine (21.2% vs. 52.5%; OR 0.15; 95% CI, 0.07 to 0.32; p<0.00001). This meta-analysis may be limited by the quality of included trials and high heterogeneity among studies. [3]

A 2020 single-center, non-blinded controlled trial including 41 patients undergoing liver transplantation evaluated sugammadex versus neostigmine for recovery after rocuronium continuous infusion. NMB was maintained by continuous intravenous (IV) infusion of rocuronium bromide (Esmeron® 50 mg/5 mL) 0.3-0.6 mg/kg/h. At the end of the surgery, either sugammadex 2 mg/kg based on actual body weight (Bridion® 100 mg/mL) or neostigmine 50 mcg/kg based on adjusted body weight plus 10 mcg/kg of atropine (Intrastigmina®, 0.5 mg/mL) were administered. The mean recovery from the NMB was significantly faster after sugammadex administration compared with neostigmine administration (9.4 ± 4.6 min vs. 34.6 ± 24.9 min; p<0.0001). No AEs were reported in either group. The authors concluded that despite considerably faster recovery time in sugammadex than that of neostigmine, further large-scale, prospective RCTs are warranted to examine its efficacy and safety in other surgical populations. [4]

Numerous studies have identified various factors that may delay the clearance of the sugammadex-rocuronium complex. Many of these factors pertain to the clinical disposition of the patient. Rocuronium excreted both biliary (> 75%) and renal excretion (26%) but the sugammadex-rocuronium complex is primarily excreted via urine (65% to 97%). Rocuronium bond to sugammadex increases urine excretion by two- to three-fold within the first 24 hours of healthy adults and surgical patients. Therefore, patients with impaired renal function can lead to prolonged exposure but the effect on the efficacy of sugammadex appears to be unaltered, and unblocking of the complex does not seem to occur. The sugammadex-rocuronium complex is characterized by a low dissociation rate (dissociation constant Kd = 0.1 × 10^-6 M) suggesting that only a minuscule fraction is completely disassociated. [5], [6], [7], [8], [9]

The nondepolarizing neuromuscular blocking agents can be divided into two classes, steroidal and benzylisoquinolinium. Steroidal neuromuscular blocking agents include rocuronium, vecuronium, and pancuronium. The benzylisoquinolinium group consists of atracurium, mivacurium, and cisatracurium. Sugammadex is approved for the reversal of steroidal agents rocuronium, along with vecuronium in non-immediate reversal situations. But sugammadex cannot reverse the benzylisoquinolinium group whereas neostigmine plus an anticholinergic agent (e.g., glycopyrrolate or atropine) may be used to reverse either nondepolarizing neuromuscular blocking classes which have not been categorized based on potency between classes. [10], [11], [12]

References:

[1] Hurford WE, Eckman MH, Welge JA. Data and meta-analysis for choosing sugammadex or neostigmine for routine reversal of rocuronium block in adult patients. Data Brief. 2020;32:106241. Published 2020 Aug 30. doi:10.1016/j.dib.2020.106241
[2] Paton F, Paulden M, Chambers D, et al. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010;105(5):558-567. doi:10.1093/bja/aeq269
[3] Subramani Y, Querney J, He S, Nagappa M, Yang H, Fayad A. Efficacy and Safety of Sugammadex versus Neostigmine in Reversing Neuromuscular Blockade in Morbidly Obese Adult Patients: A Systematic Review and Meta-Analysis. Anesth Essays Res. 2021;15(1):111-118. doi:10.4103/aer.aer_79_21
[4] Deana C, Barbariol F, D'Incà S, Pompei L, Rocca GD. SUGAMMADEX versus neostigmine after ROCURONIUM continuous infusion in patients undergoing liver transplantation. BMC Anesthesiol. 2020;20(1):70. Published 2020 Mar 25. doi:10.1186/s12871-020-00986-z
[5] Cammu G, Van vlem B, Van den heuvel M, et al. Dialysability of sugammadex and its complex with rocuronium in intensive care patients with severe renal impairment. Br J Anaesth. 2012;109(3):382-90.
[6] Staals LM, Snoeck MM, Driessen JJ, et al. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010;104(1):31-9.
[7] Hemmerling TM, Zaouter C, Geldner G, et al.Sugammadex - A short review and clinical recommendations for the cardiac anesthesiologist. Annals of Cardiac Anesthesia. 2010;10(3):206-216.
[8] Nag K, Singh DR, Shetti AN, Kumar H, Sivashanmugam T, Parthasarathy S. Sugammadex: A revolutionary drug in neuromuscular pharmacology. Anesth Essays Res. 2013;7(3):302-6.
[9] Kim YH. Repeat dosing of rocuronium-sugammadex: unpredictable. Korean J Anesthesiol. 2014;67(1):1-3.
[10] Cook D, Simons DJ. Neuromuscular Blockade. [Updated 2022 Jun 23]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538301/
[11] Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017;8(8):CD012763. Published 2017 Aug 14. doi:10.1002/14651858.CD012763
[12] Ashiru G, Carrington M. Sugammadex: routine use vs restrictive use. Br J Hosp Med (Lond). 2020;81(6):1-2. doi:10.12968/hmed.2020.0014

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

Is there a significant difference in the recovery of patients using sugammadex vs glycopyrrolate/neostigmine for the reversal of paralytics?

Please see Tables 1-2 for your response.


 

Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study

Design

Randomized, parallel-group, assessor-blinded trial

N= 151

Objective

To investigate whether reversal of rocuronium-induced neuromuscular blockade with sugammadex reduced the incidence of residual blockade and facilitated operating room discharge readiness

Study Groups

Sugammadex (n= 74)

Neostigmine/glycopyrrolate (n= 77)

Inclusion

Age of 18 years or older, undergoing elective laparoscopic or open abdominal surgery under general anesthesia with rocuronium-induced neuromuscular blockade, ASA Class I to III

Exclusion

Suspected difficult intubation, neuromuscular disorder(s), known or suspected severe renal insufficiency (CrCl <30 mL/min) or significant hepatic dysfunction, history or family history of malignant hyperthermia, allergies to sugammadex, opioids, neuromuscular blockers, or other medications used during general anesthesia, toremifene application 24 hr before or within 24 hr after study drug administration, planned ICU admission after surgery or overnight (>12 hr) stay in post-anesthesia care unit (PACU), cardiac pacemaker, pregnancy/breastfeeding

Methods

Adult patients undergoing abdominal surgery and induced by rocuronium were randomized to receive either sugammadex (2 or 4 mg/kg) or usual care with neostigmine/glycopyrrolate (dosed per the center's usual practice) for reversal of neuromuscular blockade at the end of surgery. The timing and dosing of rocuronium and reversal agents were according to the clinical judgment of the anesthesiologist. While the anesthesiologist was not blinded, the assessors in the PACU were blinded to which patients received which treatment.

Duration

From December 2011 to November 2012 

Outcome Measures

Primary: presence of residual neuromuscular blockade upon PACU admission (defined as a train-of-four (TOF) ratio <0.9)

Secondary: time between reversal agent administration, operating room discharge-readiness, adverse events (AEs)

Baseline Characteristics

 

Sugammadex (n= 74)

Neostigmine/glycopyrrolate (n= 77)

Age, years

56.4 ± 12.8 57.0 ± 12.7

Male

47 (64%) 43 (56%)

Weight, kg

95.7 ± 23.7 87.7 ± 23.8

BMI, kg/m2

32.9 ± 8.0 30.2 ± 7.0

Duration of surgery, min (range)

168 (152-185)

177 (160-195)

Intubation rocuronium dose, mg/kg

0.59 (0.06-1.56)

0.63 (0.26-1.23)

Mean maintenance dose of rocuronium, mg/kg

0.14 (0.07-0.81)

0.15 (0.04-0.59)

Number of maintenance doses of rocuronium (range)

3 (1-12)

3 (1-12)

Sugammadex dose, mg/kg (range)

4.00 (2.93-4.19)

0

Neostigmine dose, mcg/kg (range)

0 51.6 (17.1-84.8)

Glycopyrrolate dose, mcg/kg (range)

0 7.9 (2.1-17.0)

Results

 

Sugammadex (n= 74)

Neostigmine/glycopyrrolate (n= 76)

Train-of-four ratio at PACU admission

≥0.9

0.8 to <9

≥0.7 to <0.8

≥0.6 to <0.7

<0.6

 

74 (100%)

0

0

0

0

 

43 (57%)

16 (21%)

9 (12%)

3 (4%)

5 (7%)

Urinary retention

0

1 (1.3%)

Common AEs

Bradycardia

Hypertension

Hypotension

Nausea

Pneumonia

Pyrexia

Tachycardia

Vomiting

39 (52.7%)

0

10 (13.5%)

4 (5.4%)

1 (1.4%)

1 (1.4%)

7 (9.5%)

1 (1.4%)

1 (1.4%)

41 (53.2%)

4 (5.2%)

2 (2.6%)

6 (7.8%)

5 (6.5%)

4 (5.2%)

6 (7.8%)

4 (5.2%)

5 (6.5%)

Serious AEs

Acute myocardial infarction

Diarrhea

Gastrointestinal (GI) hemorrhage

Ileus

Ileus (paralytic)

Nausea

Vomiting

Pyrexia

Delayed recovery from anesthesia

Back pain

Delirium

Urinary retention

7 (9.5%%)

0

1 (1.4%)

0

3 (4.1%)

1 (1.4%)

0

0

1 (1.4%)

0

1 (1.4%)

1 (1.4%)

0

8 (10.4%)

1 (1.3%)

1 (1.3%)

1 (1.3%)

3 (3.9%)

0

1 (1.3%)

1 (1.3%)

0

1 (1.3%)

0

0

1 (1.3%)

Adverse Events

See Results

Study Author Conclusions

After abdominal surgery, sugammadex reversal eliminated residual neuromuscular blockade in the PACU and shortened the time from the start of study medication administration to the time the patient was ready for discharge from the operating room.

InpharmD Researcher Critique

Given that TOF was measured in awake patients, either voluntary or non-voluntary movements of the patient to which the thumb may be subject may have influenced the measurements. The study was not powered to detect the true differences in the incidence of postoperative respiratory complications. While sugammadex was given in a fixed dose (either 2 or 4 mg/kg), neostigmine dosing was kept at the discretion of the anesthesiologist. 

 

 
References:

Brueckmann B, Sasaki N, Grobara P, et al. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. British Journal of Anaesthesia. 2015;115(5):743–751.

 

Sugammadex use can decrease the incidence of post-operative urinary retention by avoiding anticholinergics: a retrospective study

Design

Retrospective cohort study

N=571

Objective

To compare the incidence of postoperative urinary retention (POUR) between sugammadex and anticholinergic use for reversal of muscle relaxant

Study Groups

Sugammadex (n=208)

Glycopyrrolate/pyridostigmine (n=363)

Inclusion Criteria

Underwent total knee arthroplasty, ASA class ≤3

Exclusion Criteria

Chronic kidney disease stage 3-5, bilateral total knee arthroplasty, benign prostatic hyperplasia, spinal anesthesia

Methods

All patients received propofol 2mg/kg and rocuronium 0.8mg/kg for induction and maintenance remifentanil 0.05-0.2 mcg/kg/min. The reversal agent used was either sugammadex 2 mg/kg or glycopyrrolate/pyridostigmine 0.4/15 mg and was chosen by an anesthesiologist based on personal preferences. Patients with voiding difficulties were treated with intermittent urinary catheterization.

Duration

January 2015 to December 2016

Outcome Measures

Postoperative urinary retention (POUR) defined as urinary retention of more than 400 mL due to self-voiding difficulty

Baseline Characteristics

 

Sugammadex (n=208)

Glycopyrrolate/pyridostigmine (n=363)

P-value

Age, years

70.7 ± 6.7 69.4 ± 7.0  0.033

Male

23 (11%) 29 (8.0%)

0.220

Weight, kg

62.3 ± 9.1 62.1 ± 9.4  0.800 

Medical History

Hypertension

Diabetes

Cardiovascular Disease

 

138 (66.3%)

64 (30.8%)

23 (11.1%) 

 

250 (68.9%)

97 (26.7%)

33 (9.1%) 

 

0.534

0.301

0.450 

Results

 

Sugammadex (n=208)

Glycopyrrolate/pyridostigmine (n=363)

P-value

Incidence of POUR

75 (36.1%) 177 (48.8%)   0.003

Duration of Stay, days

10.7 ± 1.7

10.9 ± 2.0

 0.240

Incidence of Urinary Cathetarization

Postoperative day 0

Postoperative day 1

Postoperative day 2

Postoperative day 3

Postoperative day 4

Postoperative day 5

 

135 (64.9%)

82 (39.4%)

40 (19.2%)

14 (6.7%)

4 (1.9%)

3 (1.4%)

 

211 (58.1%)

194 (53.4%)

116 (32.0%)

56 (15.4%)

20 (5.5%)

11 (3.0%)

 

0.111

0.001

0.001

0.002

0.040

0.238

Univariable logistic regression analysis revealed that increased age, male sex, diabetes mellitus, cerebrovascular disease, American Society of Anesthesiologists physical status classification 3, and the amount of intra-operative crystalloid increased the risk of POUR.

Adverse Events

Not assessed

Study Author Conclusions

The use of sugammadex was associated with a lower incidence of POUR by avoiding glycopyrrolate in patients underwent total knee arthroplasty.

InpharmD Researcher Critique

This study was a retrospective study of a single institution and the anesthesiologists were able to select which medication to use, which allows for confounding and biases. Furthermore, the types of opioids used in PACU and the types of fluid used during the operation were not consistent.

While the definition of urinary retention used in this study was based on previous studies, the criteria did not strictly diagnose POUR.



References:

Cha JE, Park SW, Choi YI, et al. Sugammadex use can decrease the incidence of post-operative urinary retention by avoiding anticholinergics: a retrospective study. Anesth Pain Med. 2018;13:40-46. doi:10.17085/apm.2018.13.1.40