The Effect of Dexamethasone on Sugammadex Reversal
Condition: Incomplete Reversal of Neuromuscular Block
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether dexamethasone extends the duration of
      recovery from anesthesia.
    

Detailed description: 
      After obtaining Local Ethics Committee of Cukurova University approval and written parental
      consent, this prospective, randomized, double blind, placebo-controlled study will be
      performed. Sixty patients scheduled for elective tonsillectomy or adenoidectomy, aged 3-8
      years with American Society of Anesthesiologists physical status 1 and 2 are recruited to the
      study. Exclusion criteria are the presence of respiratory, hepatic, renal and cardiovascular
      disease, oropharyngeal or facial pathology, neuromuscular disorder, hypertension and diabetes
      mellitus. Patients are randomly allocated into two groups in a 1:1 ratio by a
      computer-generated list. Allocation is provided with sealed envelopes containing group named
      paper.

      Patients are admitted to the preoperative unit 30 minutes before the operation. All patients
      are monitored with non-invasive blood pressure (NIBP), electrocardiogram (ECG), end-tidal
      carbon dioxide (ETCO2) and peripheral oxygen saturation (SpO2) in the operating room before
      the start of anesthesia induction. Anesthesia is induced with 4-5 % sevoflurane and a cannula
      (18 gauges) is placed intravenously after ensuring adequate depth of anesthesia and thus 0.9%
      of saline infusion is started at a 10 mL kg-1 hr-1 rate for hydration. Patients are received
      dexamethasone via intravenous (iv) route of 0.5 mg.kg-1 (maximum dose of 15 mg) and an equal
      volume of saline iv, in group D and group S, respectively.

      Neuromuscular monitoring is initiated after the induction of anesthesia by an
      acceleromyograph (TOF-Watch® S; Organon Ireland Ltd, Drynam Road, Swords, Co. Dublin,
      Ireland) measuring the function of adductor pollicis muscle. A transducer is attached over
      the thumb. Two electrodes are placed on cleaned skin corresponding to the ulnar nerve
      trajectory at the wrist. Stabilization and calibration are performed for TOF-Watch S
      according to good clinical research practice in pharmacodynamic studies of NMBAs.
      (Fuchs-Buder, Claudius et al. 2007) After calibration, Train of Four stimulations (TOF) are
      applied repetitively every 15 minutes for 3 minutes. Rocuronium is administered intravenously
      at a dose of 0.6 mg.kg-1 followed by calibration period. Tracheal intubation is performed
      after obtaining the adequate neuromuscular blockade. TOF stimulation is maintained every 15
      minutes until the end of anesthesia, or until the TOF ratio is 0.9. SpO2, ECG and NIBP
      monitoring with 10 minutes intervals and neuromuscular data obtained by TOF-Watch® S are
      recorded. When the T2 of the TOF reappeared, all patients are administered a single bolus
      injection of sugammadex at a dose of 2 mg.kg-1. The time to achieve a TOF ratio of 0.9 after
      sugammadex administration is recorded for all patients.

      At the end of surgery anesthesia is terminated and the awake patients are extubated. After
      extubation, patients are transported to the postoperative care unit. Pulse oximetry,
      respiratory rate and non-invasive blood pressure monitoring, the level of consciousness and
      clinical evaluation of recovery (5 s head lift test, absence of diplopia, tongue depressor
      test, and general muscle weakness) are recorded with 15 minutes intervals during 60 minutes
      in the postanesthesia care unit (PACU). Any adverse effects are recorded during the surgery
      and postoperatively for 10 hours. All records and drug administrations are performed by an
      anesthetist, who is blinded to the patient group. The primary endpoint is defined as the time
      to achieve TOF ratio to 0.9 after sugammadex administration.
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dexamethasone administration, intravenously; saline administration intravenously
Other intervention name(s): Dekort; Saline,0.9% NaCl
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Children, Dexamethasone, Sugammadex,