Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding in Thryroidectomies
Condition: Thyroid Neoplasms; Thyroid Nodule
MeSH terms: Thyroid Nodule; Thyroid Neoplasms; Thyroid Diseases; Blood Loss, Surgical
Study type: Interventional

Summary: 
      Patients undergoing thyroidectomy will be divided into three groups (30 cm H2O Group I, 40 cm
      H2O Group II, 50 cmH2O Group III). At the end of the operation patients will be applied peak
      airway pressure manually according to involved groups.The time until the first hemorrhage is
      seen in each group or if not seen pressure will be applied for 30 seconds and then will be
      ended.We will record the blood pressure, spO2, HR, the first ETCO2 after the procedure,
      postoperative haemorrhage that required surgery, and postoperative hematomas during peak
      airway pressure increase during the operation in all patients. The 1st hour blood pressure,
      nausea-vomiting score and pain score (NRS) will be recorded in the postoperative recovery
      unit.

      The primary end point of the study is intraoperative bleeding detected, and the secondary end
      point is postoperative bleeding.
    

Detailed description: 
      Patients will be divided into three groups (https://www.randomizer.org/) by computer assisted
      randomization method (30 cm H2O in Group I, 40 cm H2O in Group II, 50 cmH2O in Group III peak
      pressure will be applied). The time until the first hemorrhage is seen in each group or if
      not seen pressure will be applied for 30 seconds and then will be ended.

      Patients will be taken to the operation table and standard monitorization will be performed
      consisting of ECG, non-invasive blood pressure and peripheral O2 saturation from the back
      region. Anesthesia was induced with 2 mg / kg propofol (propofol 1% Fresenius, Fresenius
      Kabi, Germany), 2 mg / kg fentanyl (Talinat 0,5mg / 10ml, AND, Turkey), 0.6 mg / kg
      rocuronium (Muscuro 50mg / 5ml, Kocak Farma , Turkey) will be provided after the patients
      were intubated orally. General anesthesia treatment will be provided with 2% Sevoflurane in
      40% oxygen-air mixture. All patients will be ventilated in pressure controlled mode;
      respiratory frequency: 12 / min, FiO2: 40% (oxygen-air mixture), I/E:1/2, PEEP: 7 cmH2O
      supplying end tidal CO2 value of 32-36 mmHg.

      Calculating the ideal weight of the patient, isolated-S (Polifarma, Turkey)2ml/kg/h will be
      infused. If the systolic arterial pressure (SAB) or heart rate (HR) increases by 20% compared
      to baseline, IV 50 μg fentanyl will be administered. At the end of the operation, the
      patient's airway peak pressure will be increased before hemostasis is provided by the same
      surgeon (S.T.). Positive pressure on the Maquet Flow I device (Maquet Flow I-AGC, Rastatt,
      USA) will be applied manually(30 cm H2O in Group I, 40 cm H2O in Group II patients and 50 cm
      H2O in group III patients). The airway peak pressure increase will be maintained and recorded
      until the surgeon sees the first bleeding point or if not seen for 30 seconds. For all three
      groups this process will be repeated one more time.

      After peak airway pressure is increased, the number of bleeding centers detected, how long
      time did it take to detect and the size of the bleeding vessel (<2 mm or> 2 mm)will be
      recorded. We will record the blood pressure, spO2, HR, the first ETCO2 after the procedure,
      postoperative haemorrhage that required surgery, and postoperative hematomas during peak
      airway pressure increase during the operation in all patients. The 1st hour blood pressure,
      nausea-vomiting score and pain score (NRS) will be recorded in the postoperative recovery
      unit.

      The primary end point of the study is intraoperative bleeding detected, and w the secondary
      end point is postoperative bleeding.
    

Intervention name(s): peak airway pressure
Intervention type(s): Procedure
Intervention description(s): Patients' peak airway pressures will be raised to observe intraoperative bleeding in thyroidectomy surgery. Aim is to prevent postoperative bleeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care