Emergence Delirium in Children: Total Intravenous Anesthesia With Propofol and Remifentanil Versus Inhalational Sevoflurane Anesthesia
Condition: Emergence Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      Emergence delirium (ED) refers to a wide variety of behavioural disturbances that are
      commonly seen in children following emergence from anesthesia. ED can potentially be
      dangerous and have serious consequences for the child such as injury, increased pain, and
      dislodgement of medical devices, often requiring physical restraint or pharmacological
      control. Witnessing this behaviour can be stressful for parents, which can negatively affect
      their interaction with the healthcare system, and their relationship with the child, nursing
      staff and other healthcare providers. The investigators aim to minimize ED to reduce the
      distress experienced by patients and their parents. This study will compare the recovery
      profile of sevoflurane with that of propofol remifentanil and their associated incidence of
      ED. This study should enable us to determine which form of anesthesia is associated with the
      fewest incidences of ED in children.
    

Detailed description: 
      Purpose:

      In children, both propofol-only anesthesia maintenance infusions and single postoperative
      propofol boluses have been shown to be efficacious at reducing ED when compared with
      sevoflurane only [13, 17]. Methodological problems in these studies include: the
      administration of sedative premedications, ED provocative study designs that do not reflect
      reasonable clinical practice with sevoflurane, and the use of inadequately validated ED
      outcome tools.

      Based on our extensive institutional experience with TIVA, we believe that this technique is
      superior to sevoflurane with respect to the incidence of ED. However, this clinical
      impression has never been validated in an appropriately robust investigation, and sevoflurane
      remains the pediatric anesthetic of choice for most other North American pediatric
      anesthesiologists.

      Hypotheses:

        1. The use of total intravenous anesthesia (TIVA), rather than sevoflurane (SEVO) will
           reduce incidence of ED, as measured by the Pediatric Anesthesia Emergence Delirium
           (PAED) scale.

        2. The use of TIVA will not result in longer times to laryngeal mask airway removal and
           post anesthetic care unit (PACU) discharge when compared to SEVO.

      Objectives:

        1. To compare the incidence of ED between SEVO and TIVA anesthesia in children

        2. To compare times for recovery from anesthesia between the TIVA and SEVO groups

      Research Method:

      Recruitment of subjects: With institutional review board approval, and with written informed
      consent, we will recruit children, ages 2-6 years, undergoing elective strabismus surgery, a
      relatively minor eye procedure.

      Each child will be randomly assigned to one of two groups to receive either TIVA or SEVO. We
      will exclude children with ASA status IV-V, developmental delay, neurological injury,
      psychiatric diagnosis, abnormal lipid or carbohydrate metabolism, postoperative nausea or
      vomiting, Body Mass Index >30, severe anxiety in the pre-operative period requiring sedative
      premedication or complex medical conditions.

      Study design: This study is a randomized, masked clinical trial comparing induction and
      maintenance of anesthesia with TIVA to SEVO. Every effort will be made to maximize the
      masking of the observer. All patients will be scored by the Research Fellow, Dr. John
      Chandler, who will be masked to the anesthetic technique. To evaluate the pre and
      postoperative state of children we will use of the following scoring tools:

        1. The Induction Compliance Checklist (ICC) will be used to evaluate patient preoperative
           behaviour

        2. The PAED scale will be used to assess patients for ED in the PACU.

        3. Pain will be assessed postoperatively by means of the face, legs, activity, cry,
           consolability (FLACC) score currently used in the PACU

      Statistical Analysis:

      Patients with a PAED score of ≥ 10 will be classified as experiencing ED. Continuous data
      (weight, BMI) will be analyzed with t-tests and ordinal data (FLACC, PAED, ICC) with
      Mann-Whitney U tests.

      The primary hypothesis will be examined by means of a contingency table and Fisher's exact
      test.
    

Intervention name(s): Propofol; sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be anesthetised according to standard induction protocols with propofol/remifentanil intravenously. A laryngeal mask airway (LMA) will be placed by the anesthesiologist, as is usual practice for these cases. A standard dose of fentanyl (1 mcg.kg-1 IV, MAX dose 25 mcg) for postoperative pain and ondansetron (0.1 mg.kg-1 IV, MAX dose 2.5 mg) for PONV prophylaxis will be given to both groups. Dexamethasone will NOT be permitted as an additional antiemetic.; Patients will be anesthetised according to standard induction protocols with sevoflurane by inhalation. A laryngeal mask airway (LMA) will be placed by the anesthesiologist, as is usual practice for these cases. A standard dose of fentanyl (1 mcg.kg-1 IV, MAX dose 25 mcg) for postoperative pain and ondansetron (0.1 mg.kg-1 IV, MAX dose 2.5 mg) for PONV prophylaxis will be given to both groups. Dexamethasone will NOT be permitted as an additional antiemetic.
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: propofol; sevoflurane; pediatric; emergence delirium; Induction of sedation