Prophylactic Use of Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy Operation for Biliary Atresia: Double Blinded Randomized Controlled Trial
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study aims to assess the efficacy and safety of prophylactic intraoperative norepinephrine infusion versus the standard technique on decreasing the incidence of intraoperative hypotension in infants undergoing Kasai portoenterostomy operation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 4 months
Healthy Volunteers: f
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• Infants, ASA III, diagnosed as biliary atresia undergoing Kasai operation.
Locations
Other Locations
Egypt
Cairo university hospitals
Cairo
Time Frame
Start Date: 2022-08-28
Completion Date: 2024-07-08
Participants
Target number of participants: 31
Treatments
Experimental: (Group N)
1 mg norepinephrine will be diluted in dextrose 5% in a 50 mL syringe using a nomogram based on the infant body weight so that 1mL= 0.05 µg/kg/min norepinephrine infusion and the syringe will be set on 2 ml/h
Placebo_comparator: (Group S)
equivalent volume of saline will be prepared in 50 mL syringe and the infusion will be set on 2ml/kg
Related Therapeutic Areas
Sponsors
Leads: Kasr El Aini Hospital