Prophylactic Use of Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy Operation for Biliary Atresia: Double Blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Incidence of intraoperative hypotension
Study Overview
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Month to 4 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants, ASA III, diagnosed as biliary atresia undergoing Kasai operation.
Exclusion Criteria
- •Parents refusal. Patients with complex cardiac anomalies. Patients requiring emergency or laparoscopic procedures.
Arms & Interventions
(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 and the syringe will be set on 2 ml/h
Intervention: Norepinephrine Bitartrate (Drug)
(Group S)
equivalent volume of saline will be prepared in 50 mL syringe and the infusion will be set on 2ml/kg
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- heart rate(4 hours)
- Incidence of severe hypotension(4 hours)
- mean arterial pressure (MAP)(4 hours)
- Incidence of hypertension(4 hours)
- Total dose of rescue norepinephrine.(4 hours)
Investigators
Khaled Abdelfattah Abdallah Sarhan
principal investigator,Lecturer of anesthesia, Cairo university
Kasr El Aini Hospital