Preliminary Study to Assess the Effects of Total Intravenous Anesthesia With Propofol/Remifentanyl Compared to Sevoflurane/Remifentanyl for Endoscopic Sinus Surgery: Novel Approach.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised
研究概览
简要总结
The purpose of this study is to compare total intravenous anesthesia to inhaled anesthesia in endoscopic sinus surgery for chronic sinusitis. The investigators will compare bleeding during surgery, duration of surgery, blood flow to the nose and other parameters. The investigators hypothesize that total intravenous anesthesia decreases bleeding and improves the view during surgery.
详细描述
Endoscopic sinus surgery (ESS) has revolutionized the surgical treatment of chronic sinus disease, permitting outpatient sinus surgery with minimal morbidity. Previously performed using local anesthesia, the majority of patients and surgeons now prefer general anesthesia for comfort, stress containment and relative ease of accomplishing the surgical objectives1.
A critical factor in ESS is the amount of blood in the surgical field. Even for experienced endoscopists, significant bleeding may compromise the safety and completeness of the intended procedure. In addition, increased bleeding requires frequent suctioning therefore decreasing the overall efficiency of the operation and prolonging operative time.
Techniques commonly used to minimize bleeding include but are not limited to topical decongestion, local injection of vasoconstrictors, maintaining normothermia, head elevation, and controlled hypotension. However, controlled hypotension is potentially a source of excessive vasodilatation and risk factor for ischemic events. In fact, a considerable amount of data has shown that the blood pressure and intraoperative bleeding are not necessarily related, and hypotension on its own does not necessarily improve the surgical field2, 3.
In order to maintain a good peripheral perfusion the choice of anesthetics and other drugs is an important consideration. It is known that both propofol and inhalation agents have a vasodilatory effect in a concentration-dependent manner. However, the extent of reflex tachycardia is quite variable. Compared with the apparent reflex tachycardia with isoflurane, sevoflurane usually does not alter the heart rate. In contrast, propofol inhibits the baroreflex and can even result in bradycardia. In this way, propofol suppresses the cardiac output more than sevoflurane4. The lower intraoperative heart rate might help reduce the amount of intraoperative blood loss.
Few studies have attempted to demonstrate a benefit of a total intravenous anesthesia (TIVA) as the sole technique to optimize and reduce respectively blood pressure levels and bleeding5-9. Besides its potential effects on decreasing peripheral perfusion, other possible benefit of TIVA is the quality of the awakening and the reduced risk of post operative nausea and vomiting (PONV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic rhinosinusitis
- •Indication by the surgeon of need for endoscopic sinus surgery
排除标准
- •Pregnancy
研究组 & 干预措施
Total Intravenous Anesthesia
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
干预措施: Propofol and Remifentanyl (Drug)
Inhaled Anesthesia
Inhaled anesthesia with sevoflurane and remifentanyl.
干预措施: Sevoflurane and Remifentanyl (Drug)
结局指标
主要结局
Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised
时间窗: during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)
Surgeons rated the surgical field using the Boezaart score (which ranges from 0 to 5, with 5 indicating the most compromised surgical field), and this outcome measure reports the number of participants with a Boezaart score of 5. Boezaart scoring is as follows: 0 (No bleeding, cadaveric conditions); 1 (Slight bleeding, no suctioning required), 2 (Slight bleeding, occasional suctioning required; 3 (Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed); 4 (Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed); 5 (Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible).
Volume of Blood Loss
时间窗: during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)
Blood loss was determined by subtracting the volume of irrigation used intraoperatively from the total volume of fluid in the collection canisters.The Neptune Waste Management System will be used for this purpose. This is a closed suction system that digitally counts the amount of fluid suctioned.
Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)
时间窗: During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)
Thromboelastography-Platelet Mapping will be performed to assess the effect of the anesthetics on platelet function. Data are reported as Maximum Amplitude (MA) in millimeters (mm). A greater MA value indicates stronger clotting and greater platelet function.
Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System
时间窗: 60-90 minutes after induction of anesthesia
The Rhinolux system was used to measure nasal blood flow (it assessed changes in the swelling of the nasal mucosa by a tissue light absorption technique similar to that used in pulse oximetry)--negative values indicate greater nasal blood flow and less light.
次要结局
- Quality of Recovery as Indicated by Number of Participants With Nausea(During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours))
- Duration of Surgery(during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours))
- Quality of Recovery as Indicated by Pain Rating Using a Visual Analogue Scale (VAS)(During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours))
- Quality of Recovery as Indicated by Recovery Time in the PACU(During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours))
- Quality of Recovery as Indicated by Number of Participants Who Received an Analgesic Post-operatively(During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours))
研究者
Davide Cattano
Associate Professor - Anesthesiology
The University of Texas Health Science Center, Houston