Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Condition: Hypotension
MeSH terms: Hypotension
Intervention: Nitroprusside; Nitroprusside; Nitroprusside; Nitroprusside
Intervention description: Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS (Interactive Voice Response System).; Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS.; Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS.; Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS
Intervention MeSH terms: Nitroprusside
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 211.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: children; sodium nitroprusside; controlled hypotension; dose-response; pharmacokinetics; pharmacodynamics; safety; efficacy

Summary:

      Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet
      there are no controlled studies in children. The purpose of this study is to determine the
      efficacy and safety of sodium nitroprusside in children who will be having surgery, and who
      require blood pressure lowering in order to decrease the amount of blood loss during their
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        Study subjects must meet all of the following criteria:

          -  Subject is less than 17 years of age

          -  Neonates must be full-term gestation and have a body weight of at least 2.5 kg

          -  Subject requires pharmacologically-induced hypotension for acute blood pressure
             management for surgery or other invasive procedure, e.g., cerebral artery embolization

          -  Duration of the subject's controlled hypotension is expected to be ≥ 2 hours

          -  Subject requires general anesthesia with endotracheal intubation

          -  Subject requires placement of intra-arterial line during the surgical or medical
             procedure

          -  The subject's parent or legal guardian gives permission (informed consent) and subject
             gives assent when appropriate.

        Exclusion Criteria:

        Subjects will be excluded if any of the following criteria exist:

          -  Subject has a known allergy to SNP

          -  Subject has a known mitochondrial cytopathy with a disorder of oxidative
             phosphorylation or of respiratory chain enzymes

          -  Subject has a contraindication to vasodilator therapy for control of blood pressure
             during surgery or procedures

          -  Subject has participated in other clinical trials for investigational drugs and/or
             devices within 30 days prior to enrollment

          -  Subject has any serious medical condition which, in the opinion of the investigator,
             is likely to interfere with study procedures

          -  Subject is moribund (death likely to occur within 48 hours)

          -  Subject has a positive result for the urine or serum human chorionic gonadotropin
             (HCG) test administered at screening.