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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Group N) | Active Comparator | 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 S) | Experimental | the patients will receive Sugammadex 2mg/kg IV. As the reversal agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | give 2 mg/ kg as muscle reversal drug in premature infants |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluation of recovery | Time for modified Aldrete score to reach 10 | immediately after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with Complications | any complication during recovery will be noted | immediately after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasser M osman | Contact | +201006357996 | yasseralx@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Elshafie | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria university | Recruiting | Alexandria | 0203 | Egypt |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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via the closed envelope method
| Neostigmine |
| Drug |
give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants |
|
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |