Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
- Registration Number
- NCT04566796
- Lead Sponsor
- Alexandria University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description (Group N) Neostigmine patients in this group will receive 0.02 mg/kg atropine with neostigmine 0.05 mg/kg IV. to reverse the action of the neuromuscular blocker given. (Group S) Sugammadex the patients will receive Sugammadex 2mg/kg IV. As the reversal agent
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method number of patients with Complications immediately after the surgery any complication during recovery will be noted
Trial Locations
- Locations (1)
Alexandria university
🇪🇬Alexandria, Egypt