Effect of Rocuronium and Sugammadex Under Sevoflurane and Desflurane Anesthesia in Children
Condition: Anesthetics, Inhalation; Neuromuscular Blockade; Anesthesia, General
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Sugammadex is the first selective relaxant binding agent approved to reverse certain
      non-depolarizing neuromuscular drugs in patients 2 years old and above. Although it has been
      in use over the last 10 years, more pharmacological studies are needed to understand its
      overall effects on participants.

      As investigators' primary outcome, the investigators aimed to investigate how differently
      sugammadex reverses neumuscular blockade caused by rocuronium under general anesthesia
      maintenance with sevoflurane compared with desflurane. Also, to compare the changes in peak
      airway pressure. As investigators' secondary outcome, the investigators aimed to compare the
      changes in heart rate and blood pressures after sugammadex injection under sevoflurane and
      desflurane general anesthesia.
    

Detailed description: 
      160 participants aged between 2-10 years old and scheduled for lower urinary tract or minor
      abdominal surgery will be enrolled in the study. Each participant will be assigned
      sevoflurane (Group S) or desflurane (Group D) anesthesia at enrollment by drawing lots.
      Parental consent after written and verbal information will be asked on the morning of the
      surgery.

      Participants will be premedicated with midazolam (0.05 mg/kg, Zolamid, Defarma-Turkey) and
      ketamine (0.1 mg/kg, Ketalar, Pfizer-USA) and brought into operating theater. Routine
      monitoring will be done with non-invasive blood pressure (every 5 minutes), continuous
      peripheral oxygen saturation, continuous 3-lead ECG, body temperature and continuous
      end-tidal carbon dioxide measurements. Participants will be actively warmed to ensure
      normo-thermia. Train-of-four (TOF) measurements will be performed on the arm without the
      vascular access.

      Anesthesia will be induced with thiopenthal (5-6 mg/kg, Pental, Ulagay-Turkey) and fentanyl
      (2 mcg/kg, Talinat, VEM-Turkey). After the participant loses consciousness, TOF calibration
      will be performed and baseline value will be recorded. Then 0.6 mg/kg rocuronium (Myocron,
      VEM-Turkey) will be given intravenously and serial TOF measurements at 15 seconds intervals
      will be taken. The time from TOF of 100% to 0% will be recorded as T1. Participant will be
      orotracheal intubated when the TOF value is 0%. All the patients will be ventilated with
      Datex Ohmeda S/5 Avance in a volume controlled ventilation mode (air-oxygen mixture, FiO2:
      40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Participant will receive 2%
      sevoflurane (Sevoran, Abbvie-Italy) or 6% desflurane (Suprane, Baxter-Belgium) according to
      their groups.

      Non-invasive blood pressure, heart rate and peak airway pressure will be recorded at 5 minute
      intervals after orotracheal intubation. Continuous TOF measurements will be taken until TOF
      value reaches 25%. Time from TOF of 0% to 25% will be recorded as T2.

      When the TOF value is 25%, 2 mg/kg sugammadex (Bridion, MSD-Greece) will be given
      intravenously and TOF measurements will continue every 15 seconds. The time from sugammadex
      injection (TOF of 25%) to TOF of 90% will be recorded as T3. Non-invasive blood pressure,
      heart rate and peak airway pressure will be recorded at the time of sugammadex injection and
      at 1st, 2nd, 3rd and 10th minutes. Any reactions to sugammadex will be recorded (anaphylaxis,
      bronchospasm, etc.).

      T1, T2 and T3 of Group S and D will be compared. Non-invasive blood pressure, heart rate and
      peak airway pressure after sugammadex injection at time 0min, 1min, 2min, 3min and 10min will
      be compared.
    

Intervention name(s): Rocuronium; Sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): After induction, rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%.; Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given intravenously.
Other intervention name(s): Esmeron, MSD; Bridion, MSD
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Sugammadex; Sevoflurane; Desflurane; Rocuronium; TOF; Child; Train-of-four