Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy

Phase 3 Completed 31 enrolled Kasr El Aini Hospital

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start: 2022-08-28
Primary completion: 2024-07-08
Completion: 2024-07-08

Outcome

Met primary endpoint

paper 12.5% (2 patients) in the norepinephrine group compared to 75% (12 patients) in the control group PMID 40250622 ↗

paper relative risk (95% confidence interval [CI]): 0.17 (0.04-0.63), p = 0.001 PMID 40250622 ↗

Publications

Sarhan K, Ashraf N, Hasanin A, Zayed M, Saleh R, Elgohary M, Alkonaiesy R, Nawwar K. Norepinephrine infusion for preventing hypotension during hepatic exteriorization in Kasai portoenterostomy in infants with biliary atresia: A randomized controlled trial. Anaesth Crit Care Pain Med. 2025 May;44(3):101519. doi: 10.1016/j.accpm.2025.101519. Epub 2025 Apr 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Norepinephrine	Other / unclassified	0.05 ug/kg	—