Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

NCT ID: NCT04566796

Last Updated: 2020-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sugammadex

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
via the closed envelope method

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

(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.

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants

(Group S)

the patients will receive Sugammadex 2mg/kg IV. As the reversal agent

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

give 2 mg/ kg as muscle reversal drug in premature infants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sugammadex

give 2 mg/ kg as muscle reversal drug in premature infants

Intervention Type DRUG

Neostigmine

give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandria University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasser Mohamed Mohamed Osman

assistant professor of anesthesia Alexandria university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed M Elshafie

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alexandria university

Alexandria, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yasser M osman

Role: CONTACT

+201006357996

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed M osman

Role: primary

01006357996

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

234

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sugammadex as Rescue Therapy
NCT05661409 COMPLETED PHASE4