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Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy

NCT05521152 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-07-09

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Pediatrics
  • Biliary Atresia

Interventions

DRUG

Norepinephrine Bitartrate

anesthesia resident (who will not be involved in patient management to ensure the blinding) will be responsible for preparing norepinephrine infusion or placebo as instructed in the envelope as follow: 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. the attending anesthetist will be instructed to set the 2 syringe pumps on 2 mL/h continuous infusion following skin incision.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Khaled Sarhan, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521152 on ClinicalTrials.gov