Effect of Atracurium and Rocuronium on the State and Response Entropy During Isoflurane Anesthesia
Condition: Entropy Device and How Will Muscle Relaxants Affect it
MeSH terms: Muscle Hypotonia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Many studies have explored the effects of inhalation anesthetics, intravenous anesthetics,
      and muscle relaxants on spectral entropy, but most did not monitor the degree of
      neuromuscular block. In addition, they do not explore the effects of different degrees of
      neuromuscular blockade on spectral entropy under different concentrations of isoflurane
      inhalation. Therefore, the present study will evaluate different levels of MAC to quantify
      the isoflurane concentration, as well as different degrees of neuromuscular blockade
    

Detailed description: 
      The study will include 40 patients fulfilling the inclusion criteria. They will be randomized
      into 2 equal groups by a computer generated random numbers table, each consisting of 20
      patients, namely group A and group R.

        -  Group A: Patients will receive Atracurium.

        -  Group R: Patients will receive rocuronium. No premedication will be given. After the
           patients enter the operating room, a venous cannula will be inserted into a large
           peripheral vein. Data from routine monitoring, including non-invasive arterial blood
           pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal
           carbon dioxide concentration (ETCO2) will be collected. Neuromuscular blockade will be
           continuously assessed by acceleromyography using the Train-of-Four-watch SX system (made
           in Ireland), starting when the patients will be unconscious. RE and SE will be monitored
           using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system (made in
           finland).

      Baseline RE and SE will be recorded. Anesthesia will be induced by propofol (dose 2-3 mg/kg)
      and fentanyl as analgesia (dose 1-2 mg/kg). Tracheal intubation will be facilitated with
      rocuronium (dose 0.6 mg/kg) /atracurium (dose 0.5 mg/kg) after an acceleromyography count of
      0. Anesthesia will be maintained with isoflurane in an air-O2 mixture (FiO2 0.6, 2 L/min).
      Mechanical ventilation will be maintained at a tidal volume of 5-7 ml/kg. Ventilator
      frequency will be adjusted for maintenance of an ETCO2 of 35-40 mmHg. After equilibrium for
      30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at
      two levels of muscle relaxation assessed by TOF value of 50% and 100%. Rocuronium (dose
      0.01-0.012 mg/kg/min ) /atracurium (dose 0.005-0.01 mg/kg/min) will be administered as a
      continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by
      acceleromyography) will be observed. The entire experiment ended before the start of surgery.
    

Intervention name(s): Atracurium Besylate; Rocuronium Bromide; Entropy; train of four
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): Anesthesia will be induced by atracurium (dose 0.5 mg/kg).After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%. Atracurium (dose 0.005-0.01 mg/kg/min) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed. The entire experiment ended before the start of surgery. In case of hypotension (drop of blood pressure ˃20% of baseline reading), 10-30 mg of ephedrine diluted over 10 ml normal saline 0.9% will be given intravenously by titration according to the blood pressure. In case of bradycardia (heart rate less than 60 beat per minute), when it is associated with hypotension or any signs of impaired perfusion, 0.01 - 0.02 mg/kg of atropine will be given; Anesthesia will be induced by rocuronium (dose 0.6 mg/kg).After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%. Rocuronium (dose 0.01-0.012 mg/kg/min ) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed. The entire experiment ended before the start of surgery. In case of hypotension (drop of blood pressure ˃20% of baseline reading), 10-30 mg of ephedrine diluted over 10 ml normal saline 0.9% will be given intravenously by titration according to the blood pressure. In case of bradycardia (heart rate less than 60 beat per minute), when it is associated with hypotension or any signs of impaired perfusion, 0.01 - 0.02 mg/kg of atropine will be given.; No premedication will be given. After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein. Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected. Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system , starting when the patients will be unconscious. RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system.; After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein. Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected. Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system, starting when the patients will be unconscious. RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system.
Other intervention name(s): Tracium; Esmeron
Intervention MeSH terms: Bromides; Rocuronium; Atracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: Patients will receive Atracurium.
Group R: Patients will receive rocuronium.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: entropy, atracurium, rocuronium