- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04566796
Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
September 22, 2020 updated by: Yasser Mohamed Mohamed Osman, Alexandria University
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandria, Egypt, 0203
- Recruiting
- Alexandria University
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Principal Investigator:
- Yasser m osman, assistant professor
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Sub-Investigator:
- ahmed M elshafie, lecturer
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 weeks (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: (Group N)
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.
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give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants
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EXPERIMENTAL: (Group S)
the patients will receive Sugammadex 2mg/kg IV.
As the reversal agent
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give 2 mg/ kg as muscle reversal drug in premature infants
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of reversal
Time Frame: immediately after the surgery
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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
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immediately after the surgery
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Evaluation of recovery
Time Frame: immediately after the surgery
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Time for modified Aldrete score to reach 10
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immediately after the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients with Complications
Time Frame: immediately after the surgery
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any complication during recovery will be noted
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immediately after the surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed M Elshafie, Alexandria University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 11, 2020
Primary Completion (ANTICIPATED)
February 1, 2021
Study Completion (ANTICIPATED)
February 1, 2021
Study Registration Dates
First Submitted
September 16, 2020
First Submitted That Met QC Criteria
September 22, 2020
First Posted (ACTUAL)
September 28, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2020
Last Update Submitted That Met QC Criteria
September 22, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neuromuscular Manifestations
- Muscle Hypotonia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Cholinesterase Inhibitors
- Parasympathomimetics
- Neostigmine
Other Study ID Numbers
- 234
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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