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临床试验/NCT06130527
NCT06130527尚未招募不适用

Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field and Hemodynamic Parameters in Tympanomastoidectomy Cases

Erol Karaaslan0 个研究点目标入组 64 人开始时间: 2023年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
主要终点
Quality of the intraoperative surgical field

研究概览

简要总结

In the present study, the purpose was to compare the effects of Nicardipine and Remifentanil on surgical visual field and hemodynamic parameters in microscopic tympanomastoidectomy cases with Controlled Hypotension (CH).

详细描述

The visibility of the surgical field provides many advantages (e.g., preventing possible complications and reducing the duration of surgical application). In microsurgery performed in a closed and narrow area (e.g., middle ear surgery), even a small amount of blood may impair the quality of vision in the operation area and complicate the surgical intervention.

Controlled Hypotension (CH) is often preferred in some planned surgeries in reducing intraoperative bleeding, creating a quality surgical field, increasing surgical success, and reducing surgical complications. It is especially important to use it in interventions such as Functional Endoscopic Sinus Surgery (FESS), septoplasty, tympanoplasty, and vertebral surgery performed with microsurgery. As well as the advantages of CH, there is the possibility of causing various side effects by causing target organ hypoperfusion. Cerebral, renal, liver, and cardiovascular systems are the organs most affected by side effects.

Various hypotensive agents such as volatile anesthetics, sympathetic antagonists, sodium nitroprusside, nitroglycerin, hydralazine, trimethaphan, and α2 agonists are used in the literature to provide controlled hypotension.

Nicardipine is a dihydropyridine derivative vasoselective drug. Rapid onset of action i.v. nicardipine is used when rapid control of blood pressure is needed. The potential role of i.v. nicardipine was shown in many cardiovascular and neurovascular surgical procedures and surgical procedures in which CH was performed with hemostasis.

Its dromotropic effect is very low because nicardipine has no significant depressant effect on the conduction system and electrophysiological parameters of the heart. It undergoes substantial presystemic elimination in the liver after oral administration. For this reason, the rate of elimination does not change in patients with kidney failure. The elimination half-life is approximately 2 hours and slows down in patients with hepatic dysfunction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • ASA I-II patients of both sexes,
  • aged 18-65 years,
  • scheduled for tympanomastoidectomy and decided to perform CH,

排除标准

  • hypertension,
  • anticoagulant medication,
  • pregnancy
  • major hepatic,
  • cerebral, or cardiorespiratory dysfunction,
  • neurological or psychiatric disease
  • Body Mass Index BMI≥35 kg/m2,
  • difficult intubation was considered (Mallampati score 3-4, a thyromental distance less than 6 cm, maximum mouth opening less than 3 cm),
  • the number of intubation attempts more than two, cases with allergies to any of the agents used in the study

结局指标

主要结局

Quality of the intraoperative surgical field

时间窗: Measurements will be made at four different times B1: Skin incision (initial stage of surgery), B2: mastodectomy stage of surgical intervention, B3: cholestatum cleaning stage of surgical intervention, B4: grafting phase of surgical intervention

Quality of the intraoperative surgical field will be measured on a grade of 0-10 (0-1. no bleeding, 2-3. mild bleeding, 4-5. Mild to moderate bleeding, 6-7. moderate bleeding, 8-9. moderate to severe bleeding, 10. Severe bleeding)

次要结局

  • Heart rate(Measurements will be made at six different times T1: at the 20th minute of surgical intervention T2: mastodectomy stage of intervention T3: cholestatum clearing of intervention T4: grafting phase of surgical T5: first minute after extubation, T6: 10 min)
  • Mean arterial pressure(Measurements will be made at six different times T1: at the 20th minute of surgical intervention T2: mastodectomy stage of intervention T3: cholestatum clearing of intervention T4: grafting phase of surgical T5: first minute after extubation, T6: 10 min)

研究者

发起方
Erol Karaaslan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Erol Karaaslan

Associate Professor

Inonu University

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