scholarly journals Reversal of Vecuronium-induced Neuromuscular Blockade with Low-dose Sugammadex at Train-of-four Count of Four

2017 ◽  
Vol 127 (3) ◽  
pp. 441-449 ◽  
Author(s):  
László Asztalos ◽  
Zoltán Szabó-Maák ◽  
András Gajdos ◽  
Réka Nemes ◽  
Adrienn Pongrácz ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Low Dose ◽  
Neuromuscular Block ◽  
Study Drug ◽  
Neuromuscular Function ◽  
Secondary Outcome ◽  
Drug Injection ◽  
Train Of Four ◽  
Study Participants ◽  
To Receive

Abstract Background Rocuronium-induced neuromuscular block that spontaneously recovered to a train-of-four count of four can be reversed with sugammadex 0.5 or 1.0 mg/kg. We investigated whether these doses of sugammadex can also reverse vecuronium at a similar level of block. Methods Sixty-five patients were randomly assigned, and 64 were analyzed in this controlled, superiority study. Participants received general anesthesia with propofol, sevoflurane, fentanyl, and vecuronium. Measurement of neuromuscular function was performed with acceleromyography (TOF-Watch-SX, Organon Teknika B.V., The Netherlands ). Once the block recovered spontaneously to four twitches in response to train-of-four stimulation, patients were randomly assigned to receive sugammadex 0.5, 1.0, or 2.0 mg/kg; neostigmine 0.05 mg/kg; or placebo. Time from study drug injection to normalized train-of-four ratio 0.9 and the incidence of incomplete reversal within 30 min were the primary outcome variables. Secondary outcome was the incidence of reparalysis (normalized train-of-four ratio less than 0.9). Results Sugammadex, in doses of 1.0 and 2.0 mg/kg, reversed a threshold train-of-four count of four to normalized train-of-four ratio of 0.9 or higher in all patients in 4.4 ± 2.3 min (mean ± SD) and 2.6 ± 1.6 min, respectively. Sugammadex 0.5 mg/kg reversed the block in 6.8 ± 4.1 min in 70% of patients (P < 0.0001 vs. 1.0 and 2.0 mg/kg), whereas neostigmine produced reversal in 11.3 ± 9.7 min in 77% of patients (P > 0.05 vs. sugammadex 0.5 mg/kg). The overall frequency of reparalysis was 18.7%, but this incidence varied from group to group. Conclusions Sugammadex 1.0 mg/kg, unlike 0.5 mg/kg, properly reversed a threshold train-of-four count of four vecuronium-induced block but did not prevent reparalysis.

scholarly journals A Meta-Analysis on the Effect of Dexamethasone on the Sugammadex Reversal of Rocuronium-Induced Neuromuscular Block

2020 ◽  
Vol 9 (4) ◽  
pp. 1240
Author(s):  
Chang-Hoon Koo ◽  
Jin-Young Hwang ◽  
Seong-Won Min ◽  
Jung-Hee Ryu
Keyword(s):  
General Anesthesia ◽  
Neuromuscular Blockade ◽  
Primary Outcome ◽  
Elective Surgery ◽  
Neuromuscular Block ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Continuous Variables ◽  
Train Of Four ◽  
The Mean

Sugammadex reverses the rocuronium-induced neuromuscular block by trapping the cyclopentanoperhydrophenanthrene ring of rocuronium. Dexamethasone shares the same steroidal structure with rocuronium. The purpose of this study was to evaluate the influence of dexamethasone on neuromuscular reversal of sugammadex after general anesthesia. Electronic databases were searched to identify all trials investigating the effect of dexamethasone on neuromuscular reversal of sugammadex after general anesthesia. The primary outcome was time for neuromuscular reversal, defined as the time to reach a Train-of-Four (TOF) ratio of 0.9 after sugammadex administration. The secondary outcome was the time to extubation after sugammadex administration. The mean difference (MD) and 95% CI were used for these continuous variables. Six trials were identified; a total of 329 patients were included. The analyses indicated that dexamethasone did not influence the time for neuromuscular reversal of sugammadex (MD −3.28, 95% CI −36.56 to 29.99, p = 0.847) and time to extubation (MD 25.99, 95% CI −4.32 to 56.31, p = 0.093) after general anesthesia. The results indicate that dexamethasone did not influence the neuromuscular reversal of sugammadex in patients after general anesthesia. Therefore, the dexamethasone does not appear to interfere with reversal of neuromuscular blockade with sugammadex in patients undergoing general anesthesia for elective surgery.

A Low-Dose 4F-PCC Protocol for DOAC-Associated Intracranial Hemorrhage

2019 ◽  
Vol 35 (11) ◽  
pp. 1203-1208 ◽  
Author(s):  
Karen Berger ◽  
Melissa Santibañez ◽  
Lina Lin ◽  
Christine A. Lesch
Keyword(s):  
Intracranial Hemorrhage ◽  
Primary Outcome ◽  
Low Dose ◽  
Oral Anticoagulants ◽  
Secondary Outcome ◽  
Thrombotic Risk ◽  
Real World Setting ◽  
Direct Acting ◽  
Current Guidelines ◽  
Direct Acting Oral Anticoagulants

Purpose: Current guidelines favor 4F-PCC over plasma for reversal of warfarin. Uncertainty remains on the hemostatic effectiveness and thrombotic risk of 4F-PCC for direct-acting oral anticoagulants (DOACs), particularly in patients with intracranial hemorrhage (ICH). This study sought to evaluate the effectiveness and safety of a lower dose protocol of 25 units/kg 4F-PCC for the management of DOAC-associated ICH in a real-world setting. Materials and Methods: This was a retrospective study of adult patients who received at least one dose of 4F-PCC from March 2014 to December 2015 for DOAC-associated ICH. The primary outcome was hemostatic effectiveness within 24 hours. The secondary outcome was thromboembolic events within 14 days. Results: Twenty-two patients received 4F-PCC for DOAC-associated ICH and were included in the analysis. Hemostasis was evaluable in 19 patients with post-4F-PCC imaging available and occurred in 18/19 (94.7%) patients. Thromboembolism occurred in 2 out of 22 patients (9.1%). Conclusions: The use of a lower dose protocol of 25 units/kg of 4F-PCC resulted in high rates of hemostasis in patients with DOAC-associated ICH. Two patients developed thrombotic events within 14 days of 4F-PCC administration.

Extended infusion compared to standard infusion cefepime as empiric treatment of febrile neutropenia

2017 ◽  
Vol 24 (3) ◽  
pp. 170-175 ◽  
Author(s):  
Rebekah H Wrenn ◽  
David Cluck ◽  
LeAnne Kennedy ◽  
Christopher Ohl ◽  
John C Williamson
Keyword(s):  
Febrile Neutropenia ◽  
Creatinine Clearance ◽  
Primary Outcome ◽  
Clinical Success ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Secondary Outcome ◽  
Cell Transplant ◽  
To Receive ◽  
Extended Infusion

Background Extended infusion (EI) dosing provides a longer time above the minimum inhibitory concentration, which is important for the clinical success of β-lactam antibiotics, especially for patients with impaired immunity. The aim of this study was to determine the feasibility and clinical impact of administering cefepime by EI as treatment of febrile neutropenia. Methods This was a prospective, randomized, comparative pilot study. All patients received cefepime 2 g IV every 8 h, with the first dose administered using a 30-min infusion. After the first dose, patients were randomized to receive cefepime over 30 min as a standard infusion (SI) or 3 h (EI). Patients were >18 years old with febrile neutropenia (neutrophil count <500 cells/mm3 and temperature >38.0ºC) and received chemotherapy or stem cell transplant as treatment for malignancy. Patients were excluded for the following: allergy to a cephalosporin, creatinine clearance (CrCl) < 50 mL/min, receipt of concurrent Gram-negative antimicrobial, sepsis, or solid tumor malignancy. The primary outcome was defervescence by 72 h. Secondary outcomes included time to defervescence, clinical success, in-hospital mortality, hospital length of stay, and need for additional antimicrobials. Main results Sixty-three patients were enrolled: 33 in the SI arm and 30 in the EI arm. The groups were similar with regard to age, gender, weight, estimated creatinine clearance, and duration of neutropenia. None of the patients in the EI arm withdrew due to practical complications of receiving EI cefepime. Twenty-three patients in the SI arm and 20 patients in the EI arm defervesced by 72 h ( p = 0.99). There were no differences in secondary outcome measures; however, patients in the EI arm appeared to have defervesced more rapidly (median 19 vs. 41 h, p = 0.305). Conclusion Administration of cefepime by EI for the treatment of febrile neutropenia is feasible. Larger clinical trials are necessary to determine if EI cefepime imparts a clinical benefit in the treatment of febrile neutropenia.

Reversal of Neuromuscular Blockade with Sugammadex at the Reappearance of Four Twitches to Train-of-four Stimulation

2013 ◽  
Vol 119 (1) ◽  
pp. 36-42 ◽  
Author(s):  
Adrienn Pongrácz ◽  
Szilárd Szatmári ◽  
Réka Nemes ◽  
Béla Fülesdi ◽  
Edömér Tassonyi
Keyword(s):  
Neuromuscular Blockade ◽  
Study Drug ◽  
Similar Degree ◽  
Drug Injection ◽  
Stimulation Threshold ◽  
Double Blind ◽  
Randomized Controlled ◽  
Upper Limit ◽  
Rapid Reversal ◽  
Train Of Four

Abstract Background: Doses of sugammadex required to reverse deep, moderate, and shallow rocuronium-induced neuromuscular blockade have been established. However, no adequate doses for the reversal of reappearance of four twitches of train-of-four (TOF) stimulation (threshold TOF-count-four) have been established. Methods: This single-center, randomized, controlled, double-blind, four-groups parallel-arm study included 80 patients undergoing general anesthesia with propofol, sevoflurane, fentanyl, and rocuronium. Neuromuscular monitoring was performed with calibrated acceleromyography. Once rocuronium-induced neuromuscular blockade recovered spontaneously to threshold TOF-count-four, patients randomly received 0.5, 1.0, 2.0 mg/kg of sugammadex or 0.05 mg/kg of neostigmine. The time between study drug injection and reversal of TOF ratios to 1.0 was measured. Rapid reversal (≤2.0 min average, upper limit of 5.0 min) was the primary endpoint and slower reversal (≤5.0 min average, upper limit of 10 min) was the secondary endpoint of the study. Results: Sugammadex, in doses of 1.0 and 2.0 mg/kg, reversed threshold TOF-count-four to TOF ratios of 1.0 in 2.1 ± 0.8 min (mean ± SD) and 1.8 ± 0.9 min, respectively. Sugammadex, 0.5 mg/kg, induced a similar degree of reversal in 4.1 ± 1.9 min (P &lt; 0.001 vs. 1.0 and 2.0 mg/kg). Neostigmine, 0.05 mg/kg, reversed TOF ratios to 1.0 in 8.5 ± 3.5 min (P &lt; 0.001 vs. sugammadex groups). Conclusion: Sugammadex, 1.0 mg/kg, rapidly and effectively reverses rocuronium-induced block that has recovered spontaneously to a threshold TOF-count-four. A dose of 0.5 mg/kg was equally effective, but satisfactory antagonism took as long as 8 min to take place.

Aspirin Use and Post-operative Bleeding from Dental Extractions

2008 ◽  
Vol 87 (8) ◽  
pp. 740-744 ◽  
Author(s):  
M.T. Brennan ◽  
M.A. Valerin ◽  
J.L. Noll ◽  
J.J. Napeñas ◽  
M.L. Kent ◽  
...  
Keyword(s):  
Tooth Extraction ◽  
Primary Outcome ◽  
Preventive Treatment ◽  
Primary Outcome Measure ◽  
Bleeding Complications ◽  
Secondary Outcome ◽  
Dental Procedures ◽  
Secondary Bleeding ◽  
Single Tooth ◽  
To Receive

Aspirin is a common, chronically administered preventive treatment for cardiovascular disease, but is often discontinued prior to invasive dental procedures because of concern for bleeding complications. We hypothesized that aspirin does not cause increased bleeding following a single tooth extraction. Thirty-six healthy persons requiring a tooth extraction were randomized to receive 325 mg/day aspirin or placebo for 4 days. Cutaneous bleeding time (BT) and platelet aggregation tests were obtained prior to extraction. The primary outcome measure, oral BT, and secondary bleeding outcomes were evaluated during and following extraction. No significant baseline differences, except for diastolic blood pressure, were found between groups. There were no differences in oral BT, cutaneous BT, secondary outcome measures, or compliance. Whole-blood aggregation results were significantly different between the aspirin and placebo groups. These findings suggest that there is no indication to discontinue aspirin for persons requiring single-tooth extraction.

Acetyl-l-carnitine versus placebo for migraine prophylaxis: A randomized, triple-blind, crossover study

Cephalalgia ◽  
2015 ◽  
Vol 35 (11) ◽  
pp. 987-995 ◽  
Author(s):  
Knut Hagen ◽  
Eiliv Brenner ◽  
Mattias Linde ◽  
Gøril Bruvik Gravdahl ◽  
Erling Andreas Tronvik ◽  
...  
Keyword(s):  
Crossover Study ◽  
Primary Outcome ◽  
Prophylactic Treatment ◽  
Episodic Migraine ◽  
Secondary Outcome ◽  
Complete Case ◽  
Preventive Medication ◽  
Prophylactic Drug ◽  
To Receive ◽  
Blind Crossover Study

Background Preventive medication is indicated for many migraine patients, but is used in relatively few. The aim of the present study was to evaluate the efficacy of acetyl-l-carnitine as a prophylactic drug in migraine patients. Methods A single-center, randomized, triple-blind, placebo-controlled, crossover study was carried out. Men and women, age 18–65 years, with episodic migraine but otherwise healthy, were recruited mostly through advertisements. After a four-week run-in-phase, 72 participants were randomized to receive either placebo or 3 g acetyl-l-carnitine for 12 weeks. After a four-week washout, treatment was switched. The primary outcome was days with moderate or severe headache per four weeks. Secondary outcomes were days with headache, hours with headache, proportion of responders (>50% reduction in migraine days from baseline) and adverse events. Results In the complete case analyses, no statistically significant differences were found between acetyl-l-carnitine and placebo in severe or moderate headache days per month (3.0 versus 3.1, p = 0.80), headache days per month (5.1 versus 5.2, p = 0.73) or for the other secondary outcome measures. Conclusion In this triple-blind crossover study no differences were found in headache outcomes between acetyl-l-carnitine and placebo. Our results do not provide evidence of benefit for efficacy of acetyl-l-carnitine as prophylactic treatment for migraine. Trial registration: EUDRACT (2012-001624-36), ClinicalTrials.gov (NCT01695317).

Relationship of the Train-of-four Fade Ratio to Clinical Signs and Symptoms of Residual Paralysis in Awake Volunteers 

1997 ◽  
Vol 86 (4) ◽  
pp. 765-771 ◽  
Author(s):  
Aaron F. Kopman ◽  
Pamela S. Yee ◽  
George G. Neuman
Keyword(s):  
Grip Strength ◽  
Subjective Experience ◽  
Moving Objects ◽  
Neuromuscular Block ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Neuromuscular Function ◽  
Tongue Depressor ◽  
A Value ◽  
Train Of Four

Background Recovery of the train-of-four (TOF) ratio to a value &gt; 0.70 is synonymous with adequate return of neuromuscular function, but there is little information available concerning the subjective experience that accompanies residual neuromuscular block wherein the TOF ratio is in the range of 0.70 to 0.90. Methods Ten American Society of Anesthesiologists' (ASA) physical status 1 volunteers were studied. Control measurements including grip strength in kilograms and ability to perform a 5-s head- and leg-lift. In addition, a standard wooden tongue depressor was placed between each subject's incisor teeth, and he or she was told not to let the investigator remove it. All subjects were easily able to retain the device despite vigorous attempts to dislodge it. Neuromuscular function was monitored with a Datex (Datex Medical Instrumentation, Inc., Tewksbury, MA) 221 electromyographic (EMG) monitor. TOF stimulation was given every 20 s, and the measured TOF fade ratio was continuously recorded. A 5 mg/kg bolus of mivacurium was then administered, and an infusion at 2 mg.kg-1.min-1 was begun. The infusion was continued until the TOF ratio decreased to &lt; 0.70 and was adjusted to keep it in the range of 0.65 to 0.75. Signs and symptoms of weakness were recorded when the TOF ratio had been stable +/-0.03 for at least 10 min during an interval when there were no adjustments in the infusion. All tests noted previously were repeated at this time. The TOF ratio was then allowed to recover to 0.85-0.90. When stable at this level, all tests were repeated, and the infusion was discontinued. TOF measurements were continued until a ratio of 1.0 was attained and until a final set of observations was recorded. Results The TOF ratio in all subjects was reduced to &lt; 0.70. No volunteers required intervention to maintain a patient airway, and the hemoglobin oxygen saturation while breathing air was &gt; or = 96% at all times. TOF ratios &lt; or = 0.90 were accompanied by diplopia and difficulty in tracking moving objects in all subjects. The ability to strongly oppose the incisor teeth did not return until the TOF ratio (on average) exceeded 0.85. A sustained 5-s head-lift was not achieved until the TOF ratio averaged 0.60 (range, 0.45-0.75). At a TOF ratio of 0.70, grip strength averaged 59% of control (range, 50-75%). With certain exceptions (vision, ability to clench the teeth tightly), there was wide variation in symptomatology between patients for any given TOF ratio. It is impossible to give reliable TOF break-points at which symptoms and signs will be present or absent. Conclusions All subjects had significant signs and symptoms of residual block at a TOF ratio of 0.70; none considered themselves remotely "street ready" at this time. The authors believe that satisfactory recovery of neuromuscular function after mivacurium-induced neuromuscular block requires return of the TOF ratio to a value &gt; 0.90 and ideally to unity.

Early Reversal of Rapacuronium with Neostigmine 

1999 ◽  
Vol 91 (1) ◽  
pp. 51-57 ◽  
Author(s):  
Robert Purdy ◽  
David R. Bevan ◽  
Francois Donati ◽  
Lance J. Lichtor
Keyword(s):  
Neuromuscular Block ◽  
Rapid Onset ◽  
Force Of Contraction ◽  
Mean Values ◽  
Neuromuscular Relaxant ◽  
Treatment Groups ◽  
Nitrous Oxide Oxygen ◽  
Train Of Four ◽  
To Receive ◽  
Different Doses

Background Rapacuronium is a rapid-onset, short-acting neuromuscular relaxant. This multiple-center study determined neuromuscular recovery when neostigmine was given 2 or 5 min after rapacuronium. Methods One hundred seventeen patients were randomized to receive two different doses of rapacuronium and to receive neostigmine in two different doses and at two different times. During propofol anesthesia with nitrous oxide, oxygen, and fentanyl, 1.5 or 2.5 mg/kg rapacuronium was given 1 min before tracheal intubation. Neuromuscular block was measured by train-of-four ulnar nerve stimulation every 12 s: The adductor pollicis force of contraction was recorded mechanomyographically. Two or five minutes after rapacuronium was administered, 0.05 or 0.07 mg/kg neostigmine was administered and recovery was compared with that of control patients who received no neostigmine. Results Both doses of rapacuronium produced 100% block in all but one patient, who exhibited 97% block. Neostigmine accelerated recovery in all groups. After 1.5 mg/kg rapacuronium, the time to 25% T1 twitch recovery decreased from a mean of 16 min in control patients to mean values of 8-10 min in the treatment groups: The time to train-of-four ratio of 0.7 decreased from 38 min to 17-19 min. After 2.5 mg/kg rapacuronium, the time to 25% T1 was reduced from 23 min to 11-12 min, and the time to train-of-four ratio of 0.7 decreased from 54 min to 26-32 min. Recovery was not different among the the groups that received different doses and timing of neostigmine. Conclusions Recovery of intense rapacuronium block was accelerated by early neostigmine administration. When given 2 min after rapacuronium, neostigmine was as effective as after 5 min, and 0.05 mg/kg neostigmine was comparable to 0.07 mg/kg neostigmine.

scholarly journals Brief report on a phase I/IIa study to assess the safety, tolerability, and immune response of AGMG0201 in patients with essential hypertension

2021 ◽  
Author(s):  
Hironori Nakagami ◽  
Tetsuya Ishihama ◽  
Yuichi Daikyoji ◽  
Chieka Sasakura ◽  
Ei Yamada ◽  
...  
Keyword(s):  
Angiotensin Ii ◽  
Intramuscular Injection ◽  
Low Dose ◽  
Moderate Hypertension ◽  
Study Drug ◽  
High Dose ◽  
Dose Escalation Study ◽  
Immunological Responses ◽  
Single Intramuscular Injection ◽  
To Receive

AbstractWe have been developing an angiotensin II vaccine for hypertension. We conducted a placebo-controlled dose escalation study to investigate the safety, tolerability, and immunological responses of this angiotensin II vaccine (AGMG0201). AGMG0201 was administered to participants with mild to moderate hypertension between 18 and 79 years of age. Twelve patients each were enrolled in the low-dose and high-dose groups. Within each group, subjects were randomly assigned to receive either the active study drug or a placebo at a ratio of 3:1. Each participant received a single intramuscular injection, followed by a second injection 30 days later, and was monitored for 360 days after the second dose. The results showed that most treatment-related adverse events were classified as mild or moderate in severity, including pain and erythema at the injection site. Anti-angiotensin II antibodies were observed in the AGMG0201 patients, especially in the high-dose group. Overall, AGMG0201 was well tolerated.

Mivacurium When Precedent by Pancuronium Becomes a Long-acting Muscle Relaxant

1996 ◽  
Vol 84 (3) ◽  
pp. 562-565 ◽  
Author(s):  
Olli Erkola ◽  
Pekka Rautoma ◽  
Olli A. Meretoja
Keyword(s):  
Neuromuscular Block ◽  
Blocking Agent ◽  
Neuromuscular Function ◽  
Control Group ◽  
Short Acting ◽  
Nitrous Oxide Oxygen ◽  
Train Of Four ◽  
Long Acting ◽  
Written Informed Consent ◽  
Acting Muscle

Background To ensure rapid recovery of neuromuscular block, it might be useful to administer a short-acting relaxant after a long-acting one. Therefore, the interaction between pancuronium and mivacurium was investigated when mivacurium was administered during the recovery from pancuronium block. Methods After written informed consent, 41 adult patients were studied during propofol/alfentanil/nitrous oxide/oxygen anesthesia. Neuromuscular function was monitored using an electromyographic (EMG) method. AFter a stable EMG calibration response, cumulative doses of pancuronium were given to establish a 95% neuromuscular block. In the control group, and ED95 dose of 100 microg/kg mivacurium was administered instead of pancuronium. When the EMG response after pancuronium or mivacurium had recovered to 25% of the baseline, a single randomized intravenous bolus dose of 10 or 70 microg/kg mivacurium was given. Thereafter, spontaneous recovery of the neuromuscular function was recorded. Results The time from pancuronium until T1 25% EMG recovery was 38 +/- 12 min (mean +/- SD). The respective times after 10 or 70 microg/kg mivacurium were 28 +/- 8 and 54 +/- 7 min in the pancuronium group or 3 +/- 1 (n=3) and 10 +/- 4 min in the mivacurium group (P=0.0001). Times to 95% EMG recovery after 10 or 70 microgm/kg mivacurium were 77 +/- 14 and 97 +/- 16 min in the pancuronium group and 11 +/- 3 and 20 +/- 7 min in the mivacurium group, respectively (P&lt;0.0001). Recovery indexes after 10 or 70 microg/kg mivacurium group, respectively (P&lt;0.0001). Recovery indexes after 10 or 70 microg/kg mivacurium wre 26 +/- 4 and 22 +/- 6 min in the pancuronium group or 7 +/- 3 (n=3) and 5+/- 2 min in the mivacurium group, respectively (P&lt;0.0001). Times from the administration of 10 or 70 microg/kg mivacurium until train-of-four ration 0.7 were 94 +/- 16 and 111 +/- 14 min in the pancuronium group and 12 +/- 4 and 22 +/- 8 min in the mivacurium group, respectively (P&lt;0.0001). Conclusions After pancuronium, mivacurium is not a short acting neuromusclar blocking agent.

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