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临床试验/NCT04729465
NCT04729465Unknown不适用

The Effect of BIS-guided Propofol Induction on the Peroperative and Postoperative Hemodynamic Response in Patients With Cardiac Risk in Ear-nose-throat Surgery.

Istanbul University - Cerrahpasa (IUC)0 个研究点目标入组 60 人开始时间: 2021年2月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Propofol consumption

研究概览

简要总结

Anesthesia induction will be started by monitoring ECG, non-invasive artery monitoring, peripheral oxygen saturation and BIS for all patients who are taken to the operating room without sedation. The patients were divided into 2 groups: Group P; Propofol 2 mg / kg bolus (in 10 seconds), Group B; Propofol will be started as an infusion dose of 0,25 mg / kg / min and will be discontinued when the BIS reaches a minimum value of 60. Noninvasive arterial blood pressure and heart rate will be measured at 2-minute intervals during the first 10 minutes of induction and then at 15th , 20th ,30th and 60th minutes peroperatively. Hypotension; mean arterial pressure (MAP) <60 mmHg, bradycardia heart rate <60 / min, hypertension MAP> 120 mmHg and tachycardia heart rate> 100 / min were defined. The difference of changes, their duration, the difference between the maximal value and the baseline value, and the number of occurrences of hypotension, hypertension, and arrhythmias during the entire induction and perioperative period will be recorded. Noninvasive arterial blood pressure and heart rate measurements of the patients will be made in the postoperative period at 5th , 15th , 30th minutes and at 1st , 2nd , 4th , and 24th hours. At the end of the 1st month, it will be questioned whether the patients encounter a cardiovascular problem that will require treatment or hospitalization in the period following the surgery. All patients will be started with 5 ml / kg / hour IV crystalloid infusion. When the MAP falls below 60 mmHg during induction, the patient will be given the Trendelenburg position and the crystalloid infusion will be increased to 10 ml / kg / hour, and vasoconstrictor drug will be added if the hypotension does not improve within the following 10 minutes.

详细描述

surgeries performed on patients participating in the study

minor elective ear nose throat surgery (microlaryngeal surgery, biyopsy for ENT malignancy, myringoplasty)

exclusion criteria;history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females

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
Single (Participant)

盲法说明

Participant

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients with a cardiovascular problem requiring ENT surgery lasting less than 2 hours

排除标准

  • Patients having history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females were excluded from the study.

研究组 & 干预措施

Experimental

Experimental

Experimental: Bispectral Index Monitor Patients with cardiac disease receive a general anesthesia with Propofol where the amount of anesthetics administered is decided taking into consideration the Bispectral Index Monitor.

Interventions:

Drug: Propofol Device: Bispectral Index Monitor

干预措施: Propofol (Drug)

Active Comparator

Active Comparator

Active Comparator: Control Patients with cardiac disaese receive general anesthesia with Propofol

Interventions:

Drug: Propofol

干预措施: Propofol (Drug)

Experimental

Experimental

Experimental: Bispectral Index Monitor Patients with cardiac disease receive a general anesthesia with Propofol where the amount of anesthetics administered is decided taking into consideration the Bispectral Index Monitor.

Interventions:

Drug: Propofol Device: Bispectral Index Monitor

干预措施: Bispectral Index Monitor (Device)

结局指标

主要结局

Propofol consumption

时间窗: 30 minutes-2 hours

amount of Propofol consumption during the induction of anesthesia and perioperative period with or without BIS monitoring

次要结局

  • Hemodynamic alterations(30 minutes- 2 hours)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatih Yılmazer

Department of Anesthesiology, Resident, MD.

Istanbul University - Cerrahpasa (IUC)

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