Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

Sugammadex Clinical Trial

Official title:

Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566796
• Other study ID #: 234
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2020
• Est. completion date: February 2021

Study information

• Verified date: September 2020
• Source: Alexandria University
• Contact: Yasser M osman
• Phone: +201006357996
• Email: yasseralx[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Muscle Hypotonia
• Sugammadex

Intervention

Drug:
• Sugammadex
give 2 mg/ kg as muscle reversal drug in premature infants
• Neostigmine
give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants

Locations

Country	Name	City	State
Egypt	Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluation of recovery	Time for modified Aldrete score to reach 10	immediately after the surgery
Secondary	number of patients with Complications	any complication during recovery will be noted	immediately after the surgery