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AzTrials

AnesthesiaPhase 3NCT05521152

Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy

A Phase 3 study testing Norepinephrine Bitartrate in people with Anesthesia and Pediatrics, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month to 4 months
Conditions the study is for
Anesthesia, Pediatrics, Biliary Atresia
What is being tested?
Norepinephrine Bitartrate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteEgypt
Study dates
28 Aug 2022to 8 Jul 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 4 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo university hospitals

    Cairo, 11559

Other trials in Egypt

About this study

Official title: Prophylactic Use of Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy Operation for Biliary Atresia: Double Blinded Randomized Controlled Trial

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.

Read the detailed description

All children will be anesthetized in accordance with the local policy of pediatric anesthesia unit in Abu El-Reesh pediatric hospital-Cairo university.

Upon arrival to the operating room heart rate HR, noninvasive blood pressure NBP and oxygen saturation SPO2 will be monitored using standard monitor (Dräger infinity vista XL) before inhalational induction of anesthesia using titration of sevoflurane in oxygen air mixture 60% (starting from 3% up to 8%) until the child is put to sleep.

After securing an intravenous line anesthesia will be completed with 2µg/kg of fentanyl and atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained by using 1.2 % isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes. Mechanical ventilation will be set to volume-controlled mode TV:8ml/kg, I/E ratio:1/2, PEEP: 3 cmH2o and respiratory rate will be adjusted to maintain ETCO2 30-35 mmHg. Nasopharyngeal temperature probe will be inserted for monitoring of core body temperature. 22 G arterial cannula will be placed in the radial artery for continuous monitoring of arterial blood pressure and management of intraoperative hemodynamics.

Central venous catheter will be inserted under complete aseptic condition using ultrasound guidance and a Foley's catheter will be inserted in the urinary bladder.

The concealed envelopes will then be opened by an anesthesia resident (who will not be involved in patient management to ensure the blinding) and he will be responsible for preparing norepinephrine infusion or placebo as instructed in the envelope as follow:

(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.

(Group S): equivalent volume of saline will be prepared in 50 mL syringe. In both groups the attending anesthetist will be instructed to set the 2 syringe pumps on 2 mL/h continuous infusion following skin incision.

Intraoperative fluid management:

All children will receive a loading dose of 10 ml/kg of lactated ringer solution over 10 minutes after induction of anesthesia and will be maintained on 10 ml/kg/h lactated ringer solution using an infusion pump. Dextrose 1% will be transfused in a separate line and rate will be adjusted according to blood glucose level.

Packed RBCs will be transfused at a dose of 15mL/kg if intraoperative Hb dropped to 8 gm/dL.

Intraoperative hemodynamic management:

Episodes of hypotension defined as reduction of the mean ABP ≥20% of the baseline mean ABP recorded preoperatively will be managed by boluses of lactated ringer solution of 10 mL/kg that will be repeated up to 30 mL/kg, if hypotension persisted, norepinephrine bolus of 0.01 µg/kg bolus will be given, if hypotension persisted after 2 boluses the surgery will be stopped and the liver will be released into the abdominal cavity until the BP is restored. Total dose of norepinephrine will be recorded.

Hypertension defined as increase of mean ABP ≥20% of the baseline mean arterial pressure ABP will be treated by stopping the infusion pump until ABP return to baseline and then the infusion will be resumed to 1 mL/h. Bradycardia defined as HR less than 80 beat/min will be managed by atropine 0.01mg/kg.

Following release of the liver the norepinephrine infusion will be stopped gradually guided by the mean ABP.

At the end of the procedure an open transverses abdominis plane block TAPB will be given using 5 mL bupivacaine 0.25% before skin closure, inhalational anesthesia will be discontinued, infusion will be stopped and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered IV after return of patient's spontaneous breathing and patients will then be transferred to PICU.

Being tested
Norepinephrine Bitartrate, Placebo
Keywords
Kasai, biliary atresia, norepinephrine, hypotension
Medical subject headings
Biliary Atresia, Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • PlaceboDrug

    Placebo

Study groups in NCT05521152
Study groupRoleWhat they receive
(Group N)Experimental1 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
Receives: Drug: Norepinephrine Bitartrate
(Group S)Placebo comparatorequivalent volume of saline will be prepared in 50 mL syringe and the infusion will be set on 2ml/kg
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 hours

Secondary outcomes (5)
  1. mean arterial pressure (MAP)

    mean arterial pressure (MAP) will be measured upon arrival to the operating room suite as baseline and every 5 minutes after induction of anesthesia and every 3 minutes during liver mobilization till the end of surgery.

    Measured: 4 hours

  2. heart rate

    will be measured upon arrival to the operating room suite as baseline and every 5 minutes after induction of anesthesia and every 3 minutes during liver mobilization till the end of surgery.

    Measured: 4 hours

  3. Incidence of severe hypotension

    Incidence of severe hypotension defined as reduction of mean ABP ≥30% of the baseline mean ABP recorder preoperatively.

    Measured: 4 hours

  4. Incidence of hypertension

    Incidence of hypertension defined as increase of mean ABP ≥20% of the baseline

    Measured: 4 hours

  5. Total dose of rescue norepinephrine.

    Total dose of rescue norepinephrine.

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start28 Aug 2022
  3. Primary completion8 Jul 2024
  4. Study completion8 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05521152
Sponsor's protocol ID
MD-12-2021
Status last verified
Jul 2024
First submitted
28 Aug 2022
Last updated
9 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40250622

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Norepinephrine Bitartrate in people with Anesthesia and Pediatrics, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intraoperative hypotension (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05521152, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.

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