SugammadexNCT04566796
Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
A study testing Sugammadex and Neostigmine in people with Sugammadex, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Sugammadex
- What is being tested?
- Sugammadex and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2020to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm neonates
- scheduled for elective inguinal hernia repair
Who cannot join
- drug hypersensitivity
- patient is with any diseases affecting the neuromuscular junction
- Patients with family history of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria, 0203
Mohamed M osman, 01006357996, yasseralx@hotmail.com
Yasser m osman, assistant professor
About this study
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.
- Conditions
- Sugammadex
- Being tested
- Sugammadex, Neostigmine
- Keywords
- Sugammadex, preterm neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
give 2 mg/ kg as muscle reversal drug in premature infants
NeostigmineDrug
give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants
| Study group | Role | What they receive |
|---|---|---|
| (Group N) | Active comparator | 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. Receives: Drug: Neostigmine |
| (Group S) | Experimental | the patients will receive Sugammadex 2mg/kg IV. As the reversal agent Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately after the surgery
Evaluation of recovery
Time for modified Aldrete score to reach 10
Measured: immediately after the surgery
Secondary outcomes (1)
number of patients with Complications
any complication during recovery will be noted
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start11 Aug 2020
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SugammadexStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Mohamed Osman, Alexandria University
- Investigators
- Ahmed M Elshafie, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566796
- Sponsor's protocol ID
- 234
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
- ClinicalTrials.gov ID
- NCT04566796
- Acronym / sponsor ID
- 234
- Conditions
- Sugammadex
- Keywords
- Sugammadex, preterm neonates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group N) | Active comparator | Drug: Neostigminepatients 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) | Experimental | Drug: Sugammadexthe patients will receive Sugammadex 2mg/kg IV. As the reversal agent |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preterm neonates
- scheduled for elective inguinal hernia repair
Key exclusion criteria (3 listed)
- drug hypersensitivity
- patient is with any diseases affecting the neuromuscular junction
- Patients with family history of malignant hyperthermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadexgive 2 mg/ kg as muscle reversal drug in premature infants | Drug | (Group S) |
| Neostigminegive 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants | Drug | (Group N) |
Primary outcome
Assessment of reversal
Time frame: 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
Time frame: immediately after the surgery
Time for modified Aldrete score to reach 10
1 secondary outcome
number of patients with Complications
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Elshafie principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine in people with Sugammadex, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasser M osman (+201006357996, yasseralx@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of reversal (time frame: immediately after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.