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.
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.
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.
- Conditions
- Anesthesia, Pediatrics, Biliary Atresia
- 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 group | Role | What they receive |
|---|---|---|
| (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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
Incidence of hypertension
Incidence of hypertension defined as increase of mean ABP ≥20% of the baseline
Measured: 4 hours
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.
- First posted30 Aug 2022
- Study start28 Aug 2022
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
- Investigators
- Khaled Sarhan, MD, Principal investigator, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05521152
- Acronym / sponsor ID
- MD-12-2021
- Conditions
- Anesthesia, Pediatrics, Biliary Atresia
- Keywords
- Kasai, biliary atresia, norepinephrine, hypotension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group N) | Experimental | Drug: Norepinephrine Bitartrate1 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 |
| (Group S) | Placebo comparator | Drug: Placeboequivalent volume of saline will be prepared in 50 mL syringe and the infusion will be set on 2ml/kg |
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants, ASA III, diagnosed as biliary atresia undergoing Kasai operation.
Key exclusion criteria (1 listed)
- Parents refusal. Patients with complex cardiac anomalies. Patients requiring emergency or laparoscopic procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norepinephrine Bitartrateanesthesia 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 | (Group N) |
| PlaceboPlacebo | Drug | (Group S) |
Primary outcome
Incidence of intraoperative hypotension
Time frame: 4 hours
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.
5 secondary outcomes
mean arterial pressure (MAP)
Time frame: 4 hours
heart rate
Time frame: 4 hours
Incidence of severe hypotension
Time frame: 4 hours
Incidence of hypertension
Time frame: 4 hours
Total dose of rescue norepinephrine.
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 40250622Sarhan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Sarhan, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
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.