Sugammadex
Conditions
Keywords
Sugammadex, preterm neonates
Brief summary
The primary aim of the work is to compare the efficacy of Sugammadex and neostigmine in reversing rocuronium-induced muscle relaxation to reach complete recovery of neuromuscular block (TOF ratio≥ 0.9) in preterm neonates. The secondary aim is to evaluate the safety of using Sugammadex in preterm neonates and to detect any complications that may occur in this age group.
Interventions
DRUGSugammadex
give 2 mg/ kg as muscle reversal drug in premature infants
DRUGNeostigmine
give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
via the closed envelope method
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
* preterm neonates * scheduled for elective inguinal hernia repair
Exclusion criteria
* drug hypersensitivity * patient is with any diseases affecting the neuromuscular junction * Patients with family history of malignant hyperthermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of reversal | immediately after the surgery | Reversal time which is defined as time in seconds from the start of administration of sugammadex or neostigmine to recovery of TOF ratio to 0.9 |
| Evaluation of recovery | immediately after the surgery | Time for modified Aldrete score to reach 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with Complications | immediately after the surgery | any complication during recovery will be noted |
Countries
Egypt
Contacts
Primary ContactYasser M osman
Outcome results
None listed