Comparison of Normotensive Anesthesia Using a Combination of Metoprolol and Tramadol With Controlled Hypotension Using Remifentanil in Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Intraoperative Bleeding Score
研究概览
简要总结
Functional endoscopic sinus surgery (FESS) is indicated in diseases such as chronic sinusitis refractory to medical treatment, nasal polyposis, mass lesions in the nasal cavity. The purpose of this study is to determine whether tramadol and metoprolol are as effective as remifentanil in providing controlled hypotension during FESS.
详细描述
This study aims to compare two techniques for controlled hypotension during FESS. In both cases, the patients will be evaluated during the preoperative anesthetic visit, and will be given care by an anesthesiologist during the perioperative period.
Patients who are scheduled for an elective FESS operation will be included in the study. During the preoperative anaesthetic visit, patients who do not meet any of the the exclusion criteria will be offered to participate in hte study. Patients accepting to contribute tot he study will be randomised into one of the two groups via closed envelope technique.
A pilot study with 20 patients resulted in similar means and slightly different standard deviations of mean blood pressure. This pilot study showed that 44 patients in each group are sufficient to obtain 80% power with an alpha error of 0.05 and beta error of 20%. To compensate for missing/inconsistent data, or allow for better matching of the demographic variables, 3-5 additional patients will be recruited.
The anesthesiologist in charge of the patient will not be blinded to the groups, and will be responsible for maintaining the hypotension (and patient safety) with either remifentanil in one group, or tramadol and metoprolol in the other group. Systolic, diastolic, and mean blood pressures, and heart rate will be recorded into a spreadsheet every three minutes during the anaesthetic and surgical period. The data will be recorded via an excel form, which will validate the entries upon entrance. The accuracy and completeness of registry data will be verified by a third investigator, who will compare the registry data to the medical monitor records at the end of each operative day.
The surgeon will be blinded to the groups, and will be responsible for scoring the surgical vision and bleeding with the intraoperative bleeding score. The study drugs will be administered via the same type of infusion pump to facilitate the blinding process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of rhinosinusitis
- •indication for functional endoscopic sinus surgery
排除标准
- •American Society of Anesthesiologists risk score > 2
- •undertreated hypertension
- •Haemoglobin A1c test level > 7.5
- •pregnancy
- •concurrent surgery
- •history of drug abuse
- •history of or new diagnosis of allergy to any of the study drugs
- •history of post-operative nausea and vomiting
研究组 & 干预措施
remifentanil
Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
干预措施: Remifentanil (Drug)
tramadol + metoprolol
Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
干预措施: Tramadol (Drug)
tramadol + metoprolol
Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
干预措施: Metoprolol (Drug)
结局指标
主要结局
Intraoperative Bleeding Score
时间窗: throughout surgery, up to 3 hours
Intraoperative bleeding score is reported by the surgeon according to Boezaart Surgical Field Grading scale. The scale ranges from 0 to 5. '0' is the best, and '5' is the worst outcome. The scale construct is: 0 No bleeding. 1. Slight bleeding, no suction is 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. Bleeding threatens surgical field as soon as suction is removed. 5. Severe bleeding, constant suctioning required. Bleeding appears faster than suctioning. Thoroughout the intraoperative period, the surgeon is free to report a score at any time he/she sees appropriate.
次要结局
- Bleeding Rate(throughout surgery, up to 3 hours)
- Time to Achieve Intraoperative Bleeding Score < 3(throughout surgery, up to 20 minutes)
- Number of Participants With Postoperative Nausea and Vomiting(following extubation, up to 24 hours)
- Postoperative Pain(following extubation, up to 24 hours)
研究者
Başar Erdivanlı
Asst. Prof.
Recep Tayyip Erdogan University