Neuromuscular Blockade
Conditions
Keywords
sugammadex neostigmine
Brief summary
The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.
Detailed description
Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously. Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Interventions
DRUGSugammadex
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Sugammadex 0.125 mg/kg (sugammadex 0.125) Sugammadex 0.25 mg/kg (sugammadex 0.25) Sugammadex 0.5 mg/kg (sugammadex 0.5) Sugammadex 1.0 mg/kg (sugammadex 1.0) Sugammadex 2.0 mg/kg (sugammadex 2.0)
DRUGNeostigmine
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Neostigmine 10 µg/kg (Neostigmine 10) Neostigmine 25 µg/kg (Neostigmine 25) Neostigmine 40 µg/kg (Neostigmine 40) Neostigmine 55 µg/kg (Neostigmine 55) Neostigmine 70 µg/kg (Neostigmine 70) Atropine will be administered with Neostigmine at a half dose of Neostigmine administered through an intravenous line with brisk flow.
DRUGSaline 0.9%
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of saline 0.9%.
Sponsors
Guangzhou General Hospital of Guangzhou Military Command
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1 age of 18 to 65 yr, * 2 body mass index 18.5 to 25.0 kg/m2, * 3 American Society of Anesthesiologists physical status I to III * 4 scheduled for elective surgery with an expected duration of at least 60min under general anesthesia with intubation of the trachea or laryngeal mask * 5 patients having given informed consent to the study
Exclusion criteria
* 1 patients who had participated in another clinical trial within 1 month * 2 Patients with suspected difficult airway, bronchial asthma, chronic obstructive pulmonary disease * 3 known neuromuscular disease * 4 suspected malignant hyperthermia * 5 hepatic or renal dysfunction * 6 glaucoma * 7 allergy to the medication that used in this trial * 8 taking medicaments that might influence the effect of NMB agents * 9 pregnant, or breastfeeding state * 10 taking medication known to alter the effect of neuromuscular blocking agents( toremifene .etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to TOF 0.9 after the administration of reversal agent | the general anesthesia time 1 hour at least | The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of reparalysis | approximately 1 hour | Determining whether patients receiving reversal agent will have a train-to-four ratio \<0.8 during total recovery time (from TOF reach 0.9 first time to post-anaesthesia care unit (PACU) departure) |
| incidence of adverse event | the general anesthesia and recovery time 2 hours at least | Documenting whether patients will have some adverse events(such as hypoxia bradycardia nausea and vomiting) from anesthesia commence to PACU departure. |
Countries
China
Outcome results
None listed