Comparative Study of Influence of Surgical Pleth Index Guided Total Intravenous Anaesthesia (TIVA) or Volatile Anaesthesia Using Sevoflurane or Desflurane on the Intraoperative Blood Loss During Functional Endoscopic Sinus Surgery
概览
- 阶段
- 不适用
- 干预措施
- Remifentanil
- 疾病 / 适应症
- Endoscopic Sinus Surgery
- 发起方
- Medical University of Silesia
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- blood loss postoperatively
- 最后更新
- 4年前
概览
简要总结
The aim of this randomized trial is to assess the utility of Surgical Pleth Index (SPI) for monitoring pain perception intraoperatively and its influence on intraoperative blood loss, quality of surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or volatile anaesthesia using sevoflurane or desflurane
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) was 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. SPI\>10 or any SPI\>50, were proposed to constitute the indication for administration of rescue analgesia intraoperatively. This study aims at evaluating utility of SPI-guided analgesia using remifentanil on the intraoperative blood loss, haemodynamic stability and time duration of surgery in patients undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or volatile anaesthesia using sevoflurane or desflurane. 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 current literature provides conflicting findings in this area if the sort of anaesthetic used influences quality of the surgical field.
研究者
Michał Stasiowski
Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
Medical University of Silesia
入排标准
入选标准
- •written consent to participate in the study
- •written consent to undergo functional endoscopic sinus surgery under general 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 SE measurement impossible
- •necessity of administration of vasoactive drugs
研究组 & 干预措施
SEVOFLURANE INHALATIONAL ANAESTHESIA
concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanil 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% every 5 minutes until SPI value decreases back to baseline value
干预措施: Remifentanil
SEVOFLURANE INHALATIONAL ANAESTHESIA
concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanil 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% every 5 minutes until SPI value decreases back to baseline value
干预措施: surgical pleth index
DESFLURANE INHALATIONAL ANAESTHESIA
concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40,remifentanil 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% every 5 minutes until SPI value decreases back to baseline value
干预措施: Remifentanil
DESFLURANE INHALATIONAL ANAESTHESIA
concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40,remifentanil 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% every 5 minutes until SPI value decreases back to baseline value
干预措施: surgical pleth index
TIVA USING PROPOROL
infusion of propofol will be adjusted at target of SE 40, remifentanyl infusion 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% every 5 minutes until SPI value decreases back to baseline value
干预措施: Remifentanil
TIVA USING PROPOROL
infusion of propofol will be adjusted at target of SE 40, remifentanyl infusion 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% every 5 minutes until SPI value decreases back to baseline value
干预措施: surgical pleth index
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
- total consumption of remifentanil(end of operation assessment)
- SPI-guided pain perception intraoperatively(intraoperative assessment)
- condition of surgical field(intraoperative assessment)
- total consumption of propofol(end of operation assessment)
- concentration of desflurane in end-expiratory gas(intraoperative assessment)
- concentration of sevoflurane in end-expiratory gas(intraoperative assessment)
- heart rate stability intraoperatively(intraoperative assessment)