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临床试验/NCT03389763
NCT03389763已完成不适用

Comparative Study of Influence of Different Techniques of Remifentanil Titration During Functional Endoscopic Sinus Surgery Under Total Intravenous Anaesthesia (TIVA)

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年6月1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
状态
已完成
入组人数
105
试验地点
1
主要终点
blood loss postoperatively

研究概览

简要总结

The aim of this randomized trial is to assess the efficacy of analgesia , compare the utility of Pupillary Dilatation Reflex (PRD), Surgical Pleth Index (SPI) for monitoring pain perception intraoperatively and their influence on intraoperative blood loss, quality of surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing functional sinus surgery (FESS)

详细描述

Intraoperative blood loss during FESS constitutes a major problem for a surgeon because it influences quality of surgical field. Each incident of haemorrhage makes the operator stop the procedure in order to bring back the optimal visualization of the intranasal anatomy. In the end it prolongs the time of procedure.

Currently, intraoperative blood loss is estimated based on Boezaart Bleeding Scale (BBS) (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).

Recently, the Surgical Pleth Index (SPI) and Pupillary Dilatation Reflex (PRD) were added as a surrogate variable showing the nociception-antinociception balance into above mentioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. PRD value >5% reflects increased sensitivity to painful stimulus as well as delta SPI>10 or any SPI>50, and they constitute the indication for administration of rescue analgesia intraoperatively.

This study aims at evaluating utility of SPI-directed analgesia or PRD-directed analgesia or Boezaart scale-directed analgesia using remifentanil on the intraoperative blood loss, haemodynamic stability and time duration of surgery.

Currently, FESS is most often performed using total intravenous anaesthesia (TIVA) which is by majority of anaesthesiologists believed to reduce the intraoperative blood loss compared to general anaesthesia using volatile anaesthetics, but literature provides conflicting findings in this area.

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
Single (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

  • written consent to participate in the study
  • written consent to undergo functional endoscopic sinus surgery under total intravenous anaesthesia
  • ASA (American Society of Anesthesiologists) I-III

排除标准

  • age under 18 years old
  • allergy to propofol
  • pregnancy
  • any anatomical malformation making PRD or SE measurement impossible

研究组 & 干预措施

SPI-guided remifentanyl

Experimental

remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, SPI will be monitored on-line; when delta SPI>15, infusion speed of remifentanyl will be increased by 50%

干预措施: Remifentanil (Drug)

PRD-guided remifentanyl

Experimental

solution remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50%

干预措施: Remifentanil (Drug)

BBS-guided remifentanyl

Experimental

BBS assessment every 5 minutes, solution remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute; when BBS>2, infusion speed of remifentanyl will be increased by 50%

干预措施: Remifentanil (Drug)

结局指标

主要结局

blood loss postoperatively

时间窗: end of operation,' assessment

the investigators will measure the amount of blood loss in the suction bag in millilitres (ml) using a syringe after operation of FESS is completed

次要结局

  • condition of surgical field(intraoperative assessment)
  • heart rate stability intraoperatively(end of operation,' assessment)
  • hemodynamic stability intraoperatively(intraoperative assessment)
  • total consumption of propofol(end of operation assessment)
  • PRD-guided pain perception intraoperatively(intraoperative assessment)
  • SPI-guided pain perception intraoperatively(intraoperative assessment)
  • total consumption of remifentanil(end of operation assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michał Stasiowski

Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy

Medical University of Silesia

研究点 (1)

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