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Zemuron (Rocuronium Bromide) - Summary

 



ZEMURON SUMMARY

ZEMURON® (rocuronium bromide) Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration.

ZEMURON® (rocuronium bromide) Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration and is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.


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NEWS HIGHLIGHTS

Media Articles Related to Zemuron (Rocuronium)

Abdominal Surgery Without General Anesthesia
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2009.11.04]
A recent review in Faculty of 1000 Medicine Reports, a publication in which clinicians highlight advances in medical practice, suggests regional pain relief could be used during abdominal surgery. In this review, Michael Schaefer recommends a new approach that can be performed without the need for general anaesthetics.

Anesthesia, Exertional Heat Deaths May Be Linked
Source: MedicineNet Hyperthermia Specialty [2009.10.26]
Title: Anesthesia, Exertional Heat Deaths May Be Linked
Category: Health News
Created: 10/23/2009 4:10:00 PM
Last Editorial Review: 10/26/2009

Anesthesia in Youngest Kids May be Linked to Learning Disabilities
Source: MedicineNet Hernia Specialty [2009.03.25]
Title: Anesthesia in Youngest Kids May be Linked to Learning Disabilities
Category: Health News
Created: 3/25/2009 2:00:00 AM
Last Editorial Review: 3/25/2009

Need For Emergency Airway Surgery For Hard-to-Intubate Patients Reduced
Source: Respiratory / Asthma News From Medical News Today [2009.11.18]
Be prepared, that old Boy Scout motto, is being applied with great success to operating room patients whose anatomy may make it difficult for physicians to help them breathe during surgery, Johns Hopkins researchers report in a new study. When patients undergo general anesthesia, they stop breathing on their own and anesthesiologists must quickly insert a tube into the airway as a first step in machine-assisted breathing.

New Technique For Injectable Facial Fillers Improves Comfort, Recovery
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.10.29]
Less pain during injections for wrinkle-fighting facial fillers. Less swelling afterward. Less time in the office waiting for anesthesia to take effect. These and other benefits of a new injection technique that UT Southwestern Medical Center plastic surgeons are helping pioneer are outlined in the October issue of Plastic and Reconstructive Surgery.

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Published Studies Related to Zemuron (Rocuronium)

Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. [2009.10]
BACKGROUND AND OBJECTIVE: The present randomized, safety-assessor blinded, placebo-controlled trial was designed to assess safety and efficacy of sugammadex, a novel selective relaxant-binding agent, in patients with underlying cardiovascular disease undergoing noncardiac surgery... CONCLUSION: The findings indicate sugammadex 2.0 and 4.0 mg kg can be given safely and effectively for the reversal of rocuronium-induced neuromuscular blockade in patients with cardiovascular disease undergoing noncardiac surgery.

Clinical predictors of duration of action of cisatracurium and rocuronium administered long-term. [2009.09]
BACKGROUND: The duration of action of neuromuscular blocking drugs (NBDs) varies between individuals and even within individuals in different settings. OBJECTIVES: To define predictors of variance in duration of action of rocuronium and cisatracurium administered long-term... CONCLUSION: Duration of NBD treatment is strongly predictive of the duration of action of rocuronium, and body temperature is predictive of the duration of action of cisatracurium. These data may help decrease the incidence of drug-induced muscle weakness in recovery rooms and surgical intensive care units, particularly if neuromuscular transmission monitoring is not available.

Should dosing of rocuronium in obese patients be based on ideal or corrected body weight? [2009.09]
BACKGROUND: Pharmacokinetic studies in obese patients suggest that dosing of rocuronium should be based on ideal body weight (IBW). This may, however, result in a prolonged onset time or compromised conditions for tracheal intubation. In this study, we compared onset time, conditions for tracheal intubation, and duration of action in obese patients when the intubation dose of rocuronium was based on three different weight corrections... CONCLUSIONS: In obese patients undergoing gastric banding or gastric bypass, rocuronium dosed according to IBW provided a shorter duration of action without a significantly prolonged onset time or compromised conditions for tracheal intubation.

Reversal of neuromuscular blockade by sugammadex after continuous infusion of rocuronium in patients randomized to sevoflurane or propofol maintenance anesthesia. [2009.07]
BACKGROUND: Sugammadex rapidly reverses neuromuscular blockade induced by bolus rocuronium doses, but it has not been investigated after continuous rocuronium infusion in surgical patients. We therefore examined the clinical effect of sugammadex for neuromuscular blockade induced by continuous rocuronium infusion in adults undergoing surgery under maintenance anesthesia with sevoflurane or propofol... CONCLUSIONS: Single-dose sugammadex (4 mg/kg) after continuous rocuronium infusion is equally effective and well tolerated during maintenance anesthesia with sevoflurane or propofol.

Excellent intubating conditions with remifentanil-propofol and either low-dose rocuronium or succinylcholine. [2009.07]
PURPOSE: The shortest time to tracheal intubation, the best intubating conditions, and the shortest duration of muscle paralysis are achieved with succinylcholine. During a lidocaine-remifentanil-propofol induction of anesthesia, we compared intubating conditions 90 s after administering low-dose rocuronium (0.3 mg . kg(-1)) with intubating conditions 60 s after administering succinylcholine 1.5 mg . kg(-1)... CONCLUSION: During a lidocaine-remifentanil-propofol induction of anesthesia, rocuronium 0.3 mg . kg(-1) administered before the induction sequence provides intubating conditions comparable to those achieved with succinylcholine 1.5 mg . kg(-1) administered after the induction sequence.

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Clinical Trials Related to Zemuron (Rocuronium)

A Study to Determine the Dose Requirements of Rocuronium Bromide (ZemuronŽ) in Pediatric and Adolescent Subjects [Completed]
The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to <28 days old), infants and toddlers (28 days to less than or equal to 24 months old), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age).

A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia [Completed]

The Effect of Rocuronium on the Response of Composite Variability Index (CVI) to Laryngoscopy [Recruiting]
Eighty subjects will be recruited from those scheduled for surgery requiring general anesthesia at St Vincent's Hospital. Subjects must have American Society of Anesthesiologists (ASA) status of 1 or 2 (be fairly healthy), a BMI between 18-35 (reasonably healthy weight), and be between the ages of 18 and 75. They will not be eligible if they take certain medications or are expected to have a difficult intubation.

Subjects will be randomized (assigned by chance) to one of four rocuronium doses of 0, 0. 2, 0. 4, or 0. 6 mg kg-1. All are acceptable clinical doses for performing a laryngoscopy. In the operating room, routine monitors will be applied, including a Bispectral Index (BIS) sensor and an M-Entropy sensor. Subjects will receive 0. 025 mg kg-1 midazolam (a standard pre-op dose) and will be put to sleep. Once asleep, the subject will receive a rocuronium dose, followed by laryngoscopy three minutes later. The anesthesiologist performing the laryngoscopy will not know what dose of rocuronium the subject received. CVI, entropy, amount of muscle relaxation, and vital signs will be monitored and recorded throughout the procedure.

Subjects will receive propofol and remifentanil infusions during the case. These are commonly used medications for anesthesia. The subjects will also be randomized to two additional groups. One group will receive a remifentanil infusion of 2ng ml-1 and the other group will receive a 8ng ml-1 remifentanil infusion. Both doses are acceptable and often used during standard clinical care. The propofol infusion will be adjusted to keep the BIS number between 45-60. The anesthesiologist will not be able to see the CVI value. The times of certain intraoperative events, such as intubation and incision, will be recorded. All subjects will receive a morphine bolus (0. 10-0. 15 mg/kg) towards the end to reduce post-operative pain, as per standard clinical care. As the subject wakes up, time to eye opening and orientation will be recorded. The subject will rate their pain on a numerical pain scale and the quality of emergence will be assessed.

Upon arrival in the post anesthesia care unit (PACU), subjects will be asked to rate their pain again using the same pain scale. The pain score will be evaluated every 10 minutes for half an hour, then every hour until they are discharged from PACU.

Pharmacodynamic Trial on Rocuronium in Obese Patients [Completed]
Aim: To optimize the use of rocuronium (a neuromuscular blocking agent) in obese patients undergoing gastric bypass or gastric banding.

Background: During general anaesthesia, a neuromuscular blocking agent is needed to allow surgery and airway management. Optimal dosing is important in order to avoid inadequately muscle relaxation, but also to avoid overdosage, which can result in prolonged anaesthesia and respiratory complications.

Main hypothesis: Rocuronium dosed according to ideal body weight results in shorter duration of action compared to rocuronium dosed according to corrected body weight without prolonged onset time or compromised airway management or surgical demands for muscle relaxation.

Org 25969 After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia [Completed]
The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4. 0 mg. kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium, between subjects receiving maintenance anesthesia using propofol and subjects receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in subjects after continuous infusion of rocuronium and before the administration of Org 25969, under either propofol or sevoflurane anesthesia.

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Page last updated: 2009-11-18

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