Emergence Agitation Between Sevoflurane and Desflurane in Pediatric
Condition: Children; Urologic Diseases; Ambulation Difficulty
MeSH terms: Psychomotor Agitation; Emergence Delirium; Urologic Diseases; Mobility Limitation
Study type: Interventional

Summary: 
      Sevoflurane is the volatile anesthetic agent of choice in pediatric surgery. Nevertheless,
      sevoflurane anesthesia had the high incidence of emergence delirium compared to halothane and
      isoflurane.Bortone L et al.reported isoflurane for maintenance decreased incidence of
      emergence agitation compared to sevoflurane in unpremedicated preschool children under
      elective subumbilical surgery (32% versus 52% respectively). Desflurane is the new volatile
      anesthetic agent which provides faster recovery compared to sevoflurane.Valley et al.reported
      no significant differences between sevoflurane or desflurane anesthesia in children in term
      of the serious airway complication such as laryngospasm or desaturation excepted the number
      of coughing episodes were more frequent in the desflurane compared to sevoflurane (36 versus
      18).Mayer J et al. reported sevoflurane had severity of Pediatric Anesthesia Emergence
      Delirium (PAED) scale higher than desflurane in ear, nose, throat inpatient surgery in
      children (12(2-20) versus 6(0-15) respectively) with no reported of incidence of emergence
      agitation between those two. Therefore, the investigators would like to compare the incidence
      of emergence agitation, recovery profile and respiratory events between desflurane and
      sevoflurane anesthesia in pediatric ambulatory urologic surgery under general anesthesia and
      combined with regional anesthesia.
    

Detailed description: 
      After institutional review board (Prince of Songkla University, Songkhla, Thailand) approval
      and written informed consent from parents, 136 children aged 1-9 years, with American Society
      of Anesthesiologists (ASA) physical status I or II ,scheduled to undergoing elective
      ambulatory urologic surgery under general anesthesia combined with regional block , were
      prospectively enrolled in the study. Children were randomized by a computer-generated program
      to either sevoflurane group (group s, n =68) or desflurane group (group d, n =68) for
      maintenance of anesthesia . Exclusion criterion included emergency procedures, medical
      contraindication to placement of a caudal block, mental retardation, developmental delay,
      attention-deficit/hyperactivity disorder, psychiatric illness, a history of paradoxical
      excitation with sedatives. Children did not receive any premedication. Parents were allowed
      to be present for induction. Children's behavior was assessed at the time of separation from
      parents by using a separation scale 1-4 (1= excellent [separates easily] , 2= good [not
      clinging, whimpers ,calm with reassurance] , 3 = fair [not clinging , cried , will not calm
      or quiet] , 4 = poor [crying , clinging to parent]11 . A separation score of 1 or 2 was
      considered satisfactory , whereas a score of 3 or 4 was considered unsatisfactory. An
      induction scale 1-4 was used to assess acceptance of the anesthetic mask ( 1 = excellent
      [unafraid, co-operate, accepts mask readily], 2 = good [slight fear of mask , easily calmed]
      , 3 = fair[ moderated fear , not calmed with reassurance] ,4 = poor [terrified , crying
      ,agitated]11. An induction score of 1 or 2 was considered satisfactory , whereas a score of 3
      or 4 was considered unsatisfactory. Then , children received a mask induction with either
      incremental sevoflurane 2-8% or single breath sevoflurane 8% in a 70 % nitrous oxide and 30%
      oxygen mixture with a 10 L/min fresh gas flow. After inhalation anesthetic induction , an
      intravenous cannula were place. Ventilation was controlled by laryngeal mask airway (LMA).
      After established the airway, children were assigned to receive either sevoflurane or
      desflurane by adjusting end-tidal concentration to deliver a minimum alveolar anesthetic
      concentration(MAC) of 1. The nitrous oxide in oxygen concentration was reduced to 66% and
      total gas flow rate was reduced to 5 LMP . All regional block; penile block, ilioinguinal
      nerve block and caudal block , were performed by discretion of attending anesthesiologist
      based on routine practice and type of operation.

      Intraoperative analgesics or other sedative drug were not given unless the child's heart rate
      increase > 20% of baseline after incision or during operation and then fentanyl 0.5-1 mcg/kg
      intravenously was given to supplement analgesia throughout the operation. At the start of
      surgical closure, the inhaled anesthetic was discontinued. When the wound closure was
      completed , the nitrous oxide was discontinued with the oxygen flow rate was increase to 10
      LMP. The awake LMA removal was followed by extubation criteria. The children were then
      transported to the post-anesthetic care unit (PACU). The awakening time defined by the time
      after discontinued inhaled agent until LMA was removed. Duration of surgery and anesthesia
      were also recorded. The emergence agitation score was assessed by 3 experienced PACU nurse,
      blinded to the inhaled anesthetic agents. The emergence agitation score 1-4 and duration of
      agitation were measured in the PACU (1= awake and calm , cooperative ; 2 = crying, requires
      consoling ; 3 = irritable/restless , screaming , inconsolable ; 4 = combative ,disoriented,
      thrashing)11. Children with an agitation score of 3 or 4 were classified agitated. Parent
      were reunited with their children in the PACU after an initial admission and stabilization
      phase. The pain score 1-10 using the FLACC under the age of 5 and the Face Pain Scale or the
      Numeric Rating Scale in older children was assessed by the same PACU nurse. If the children
      had severely agitated by agitation score > 3 for 5 minutes or pain score ≥ 4, the fentanyl
      0.5 mcg/kg was administered intravenously every 10-15 min for treatment of agitation or
      rescue analgesia. Maximum agitation score and maximum pain score were recorded in the PACU.
      Duration in PACU stay defined by the time arrived in the PACU until discharge from PACU were
      also recorded. Intraoperative respiratory adverse events and PACU adverse events were
      recorded.

      Primary objective was to compare the incidence of emergence agitation between sevoflurane
      anesthesia and desflurane anesthesia in pediatric ambulatory urologic surgery. Secondary
      objectives were to compare the recovery profile such as awakening time. Duration of PACU
      stay, and also intraoperative and PACU respiratory adverse events between sevoflurane
      anesthesia and desflurane anesthesia.

      The statistic analysis The sample size calculation by program R 2.8.1 was based on the
      incidence of sevoflurane induced emergence agitation 52% by Bortone, et al 4 . the
      investigators calculated a sample size of 62 subjects per treatment arm wound have at least
      an 80% power to detect desflurane reduced of 50% compared to sevoflurane in the incidence of
      emergency agitation. The calculation was included the 10% dropout of the study, so 136
      children were enrolled in the study.

      Date were reported as mean±SD , median (range). Continuous data such as age, weight. duration
      of surgery, duration of anesthesia, awakening time, onset of agitation , duration of
      agitation, duration of PACU stay and PACU pain score were analyzed by unpaired Student's
      test. Categorical data such as gender , ASA physical status, a separation scale, an induction
      scale, type of operation, type of operation, an emergence agitation scale, intraoperative and
      PACU adverse events were compared using the Pearson's chi-square test. Incidence of emergence
      agitation and other adverse events were reported as number and percent (n, %). A P value of
      0.05 was considered for statistical significance.
    

Intervention name(s): Desflurane; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Desflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery; Sevoflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery
Other intervention name(s): Suprane (desflurane, USP); sevorane
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: incidence; emergence agitation; sevoflurane; desflurane; ambulatory pediatric surgery