跳至主要内容
临床试验/NCT01470898
NCT01470898Unknown4 期

Effect of Bispectral Index (BIS) Monitoring on Faster Recovery Time and Analgesic Consumption in Abdominal Surgery Patients

University Hospital Dubrava2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年2月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
40
试验地点
2
主要终点
Bispectral index (BIS) monitoring in abdominal surgery patients

研究概览

简要总结

Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. The aim of the study was to investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative anesthesia consumption.

详细描述

Patients undergoing major abdominal surgery under general anesthesia in University Hospital Dubrava, were eligible if there were aged 18 years or older, and ASA (American Society of Anesthesiologists) physical status II or III. Study included 40 patients enroled in the six months period (between February 2011. and July 2011.). Exclusion criteria were memory impairment, psychosis, known or suspected electroencephalograph abnormality (eg, epilepsy, previous brain operation), chronic use of psychoactive medication, and operation time exceeding six hours.

The protocol was approved by Institutional Ethics Committee of University Hospital Dubrava. All participating elective surgical patients were given brief description of the trial, and gave written informed consent before enrolment.

According to a computer generated randomisation list, patients were randomly assigned to receive BIS-guided anesthesia (group 1) or routine anesthesia care as a non BIS-guided group (group 2). The non BIS-guided group was studied while the BIS monitor was attached to patient, but the screen was blinded to the anesthesiologist in charge. All values were recorded by the younger anesthesiologist, who was not involved in the anesthesia maintenance. All other aspects of perioperative treatment were similar, including choice of anesthetic agents and monitoring.

The operation was performed under general anesthesia using midazolam (0.15 mg/kg), fentanyl (2 µg/kg) and pancuronium (0.1 mg/kg) to facilitate endotracheal intubation, and 1.5-2.5 MAC of sevoflurane, nitrous oxide 50% in oxygen, boluses of fentanyl and pancuronium for maintenance. Intraoperatively, after induction doses of fentanyl, anesthesia was mainly balanced with sevoflurane. Electrocardiography (EKG), invasive blood pressure (IBP), peripheral oxygen saturation (SpO2), and end-tidal CO2 (etCO2) were monitored.

A BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation [3].

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
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

入选标准

  • patients undergoing major abdominal surgery under general anesthesia in University Hospital Dubrava, were eligible if there were aged 18 years or older
  • ASA (American Society of Anesthesiologists) physical status II or III.

排除标准

  • memory impairment,
  • psychosis,
  • known or suspected electroencephalograph abnormality (eg, epilepsy, previous brain operation),
  • chronic use of psychoactive medication,
  • operation time exceeding six hours.

结局指标

主要结局

Bispectral index (BIS) monitoring in abdominal surgery patients

时间窗: six months

At the induction of anesthesia, and every 15 minutes during operation BIS levels were recorded.

次要结局

  • Effect of bispectral index (BIS) monitoring on faster recovery time in abdominal surgery patients(six months)

研究者

发起方
University Hospital Dubrava
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jasminka Persec, MD, PhD

MD PhD

University Hospital Dubrava

研究点 (2)

Loading locations...

相似试验