None listed
Conditions
Brief summary
Sixty children age between 2-12 in ASA I-II scheduled for elective surgery in supine position were enrolled to this randomized, prospective, double-blinded study after the permission of local ethics committee and parents written informed consent. Patients were randomized to two groups as Group I (sugammadex) and Group II (neostigmine). Propofol (2mg/kg) and fentanyl (1?g/kg) were administered for induction and sevoflurane for maintenance of anaesthesia. Neuromuscular function was monitored by acceleromyography (TOF Watch SX) and train-of-four (TOF) mode of stimulation. Rocuronium (0.6mg/kg) was used for NMB and 0.1-0.2 mg/kg additional doses were given if necessary. At reappearance of T2, sugammadex 2mg/kg in group I and neostigmine 0.06mg/kg+atropine 0.02 mg/kg in group II were administered. Patients were extubated after TOF 0.9 was achieved. No statistically significant difference was observed between the groups according to age, gender, weight, duration of operation, mean arterial pressure, SpO2, fentanyl and rocuronium usages (p>0.05).Heart rate decreased significantly after reversal agent in group I at 15th,30th and 60th seconds of evaluation whereas it increased significantly in group II (p<0.0004).Time from administration of reversal agent to TOF 0.9 was faster with sugammadex (68 second) than with neostigmine (392 second) (p<0.001). Muscle strength was significantly higher in group I than in group II. The result of this study shows sugammadex is a safe and effective agent for reversing rokuronium–induced NMB in paediatric patients with a faster recovery of neuromuscular function than neostigmine.
Interventions
2mg/kg sugammadex intravenously will be given only once when T2 point (two contractions) on TOF device is observed in group I patients.
TOF device is used for evaluating the level of neuromuscular block after neuromuscular blocker medications. Entubation and extubation time of the patient decided correctly and easily by using this device. Different kinds of electrical stimulations are used like;Train-Of-Four Ratio,Single twitch,Double-burst stimulation, Post-tetanic count. We used TOF device du
2mg/kg sugammadex intravenously will be given only once when T2 point (two contractions) on TOF device is observed in group I patients. TOF device is used for evaluating the level of neuromuscular block after neuromuscular blocker medications. Entubation and extubation time of the patient decided correctly and easily by using this device. Different kinds of electrical stimulations are used like;Train-Of-Four Ratio,Single twitch,Double-burst stimulation, Post-tetanic count. We used TOF device during the surgery started after anesthesia induction (before neuromuscular blocker agent was given) to extubation time .
Sponsors
Ministry of Health Ankara Training and Research Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Pediatric patients age between2-12 and ASA1-2 whom should be performed general anesthesia in supine position for ear nose and throat surgery.
Exclusion criteria
Exclusion criteria were; intubation limitations, drug uptake that can cause interaction with rocuronium, neuromuscular diseases, renal diseases and known malign hyperthermia in the family history.
Outcome results
None listed