NCT05521152

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

August 28, 2022

Last Update Submit

July 7, 2024

Conditions

AnesthesiaPediatricsBiliary Atresia

Keywords

Kasaibiliary atresianorepinephrinehypotension

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative hypotension

    Incidence of intraoperative hypotension defined as persistent reduction of mean ABP ≥20% of the baseline mean ABP recorder preoperatively requiring release of the liver after initial resuscitation.

    4 hours

Secondary Outcomes (5)

  • mean arterial pressure (MAP)

    4 hours

  • heart rate

    4 hours

  • Incidence of severe hypotension

    4 hours

  • Incidence of hypertension

    4 hours

  • Total dose of rescue norepinephrine.

    4 hours

Study Arms (2)

(Group N)

EXPERIMENTAL

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

Drug: Norepinephrine Bitartrate

(Group S)

PLACEBO COMPARATOR

equivalent volume of saline will be prepared in 50 mL syringe and the infusion will be set on 2ml/kg

Drug: Placebo

Interventions

Norepinephrine BitartrateDRUG

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.

(Group N)
PlaceboDRUG

Placebo

(Group S)

Eligibility Criteria

Age1 Month - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants, ASA III, diagnosed as biliary atresia undergoing Kasai operation.

You may not qualify if:

  • Parents refusal. Patients with complex cardiac anomalies. Patients requiring emergency or laparoscopic procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, 11559, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 40250622DERIVED

MeSH Terms

Conditions

Biliary AtresiaHypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Khaled Sarhan, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator,Lecturer of anesthesia, Cairo university

Study Record Dates

First Submitted

August 28, 2022

First Posted

August 30, 2022

Study Start

August 28, 2022

Primary Completion

July 8, 2024

Study Completion

July 8, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)