Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2020
CompletedFirst Submitted
Initial submission to the registry
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedSeptember 28, 2020
September 1, 2020
6 months
September 16, 2020
September 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assessment of reversal
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
immediately after the surgery
Evaluation of recovery
Time for modified Aldrete score to reach 10
immediately after the surgery
Secondary Outcomes (1)
number of patients with Complications
immediately after the surgery
Study Arms (2)
(Group N)
ACTIVE COMPARATORpatients 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)
EXPERIMENTALthe patients will receive Sugammadex 2mg/kg IV. As the reversal agent
Interventions
give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants
Eligibility Criteria
You may qualify if:
- preterm neonates
- scheduled for elective inguinal hernia repair
You may not qualify if:
- drug hypersensitivity
- patient is with any diseases affecting the neuromuscular junction
- Patients with family history of malignant hyperthermia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria university
Alexandria, 0203, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed M Elshafie
Alexandria University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- via the closed envelope method
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor of anesthesia Alexandria university
Study Record Dates
First Submitted
September 16, 2020
First Posted
September 28, 2020
Study Start
August 11, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
September 28, 2020
Record last verified: 2020-09