Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

Alexandria University

Status: Unknown

Conditions: Sugammadex

Treatments: Drug: Sugammadex; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT04566796

234

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

(Group N)

Active Comparator group

Description:

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.

Treatment:

Drug: Neostigmine

(Group S)

Experimental group

Description:

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

Treatment:

Drug: Sugammadex