Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

• Sponsor: Alexandria University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04566796
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.7
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sugammadex	Drug: Sugammadex; Drug: Neostigmine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: via the closed envelope method
• Primary Purpose: Treatment
• Official Title: Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
• Actual Study Start Date: Aug 11, 2020
• Anticipated Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

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.	Drug: Neostigmine; give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants
Experimental: (Group S) the patients will receive Sugammadex 2mg/kg IV. As the reversal agent	Drug: Sugammadex; give 2 mg/ kg as muscle reversal drug in premature infants

Outcome Measures

Primary Outcome Measures

1. Assessment of reversal [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

2. Evaluation of recovery [immediately after the surgery]

   Time for modified Aldrete score to reach 10

Secondary Outcome Measures

1. number of patients with Complications [immediately after the surgery]

   any complication during recovery will be noted

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 28 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria university	Alexandria		Egypt	0203

Sponsors and Collaborators

• Alexandria University

Investigators

• Principal Investigator: Ahmed M Elshafie, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yasser Mohamed Mohamed Osman, assistant professor of anesthesia Alexandria university, Alexandria University
• ClinicalTrials.gov Identifier: NCT04566796
• Other Study ID Numbers: 234
• First Posted: Sep 28, 2020
• Last Update Posted: Sep 28, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yasser Mohamed Mohamed Osman, assistant professor of anesthesia Alexandria university, Alexandria University: Sugammadex; preterm neonates
• Additional relevant MeSH terms: Muscle Hypotonia; Neostigmine

Study Results

No Results Posted as of Sep 28, 2020