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临床试验/NCT03547648
NCT03547648已完成不适用

Comparison of the Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding Points in Thyroidectomies

Istanbul University2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2018年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
2
主要终点
Intraoperative bleeding point

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA classification I-II patients
  • Patients undergoing total thyroidectomy
  • Aged between 18-60 years

排除标准

  • Active pulmonary disease
  • Cardiac aritmia
  • Intracranial mass
  • Coagulation defects

研究组 & 干预措施

Group I ( 30 cm H2O)

Active Comparator

Patients will be applied 30 cm H2O peak airway pressure manually at the end of the surgery

干预措施: peak airway pressure (Procedure)

Group II( 40 cm H2O)

Active Comparator

Patients will be applied 40 cm H2O peak airway pressure manually at the end of the surgery

干预措施: peak airway pressure (Procedure)

Group III(50 cm H2O)

Active Comparator

Patients will be applied 50 cm H2O peak airway pressure manually at the end of the surgery

干预措施: peak airway pressure (Procedure)

结局指标

主要结局

Intraoperative bleeding point

时间窗: 30 seconds

Determination of intraoperative bleeding point just after applying positive airway pressure manually

次要结局

  • postoperative haemorrhage(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Cigdem Akyol Beyoğlu

Anaesthesiologist

Istanbul University

研究点 (2)

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