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Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

Primary Purpose

Sugammadex

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Sugammadex

Neostigmine

About this trial

This is an interventional treatment trial for Sugammadex focused on measuring Sugammadex, preterm neonates

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept 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

Sites / Locations

Alexandria universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

(Group N)

(Group S)

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Evaluation of recovery

Time for modified Aldrete score to reach 10

Secondary Outcome Measures

number of patients with Complications

any complication during recovery will be noted

Full Information

NCT ID

NCT04566796

First Posted

September 16, 2020

Last Updated

September 22, 2020

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04566796

Brief Title

Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

Official Title

Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 11, 2020 (Actual)

Primary Completion Date

February 2021 (Anticipated)

Study Completion Date

February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sugammadex

Keywords

Sugammadex, preterm neonates

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

via the closed envelope method

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

(Group N)

Arm Type

Active Comparator

Arm 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.

Arm Title

(Group S)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sugammadex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Neostigmine

Intervention Description

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

Primary Outcome Measure Information:

Title

Assessment of reversal

Description

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

Time Frame

immediately after the surgery

Title

Evaluation of recovery

Description

Time for modified Aldrete score to reach 10

Time Frame

immediately after the surgery

Secondary Outcome Measure Information:

Title

number of patients with Complications

Description

any complication during recovery will be noted

Time Frame

immediately after the surgery

10. Eligibility

Sex

All

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yasser M osman

Phone

+201006357996

yasseralx@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed M Elshafie

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alexandria university

City

Alexandria

ZIP/Postal Code

0203

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed M osman

Phone

01006357996

yasseralx@hotmail.com

First Name & Middle Initial & Last Name & Degree

Yasser m osman, assistant professor

First Name & Middle Initial & Last Name & Degree

ahmed M elshafie, lecturer

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

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