Comparative Study of Influence of Total Intravenous Anaesthesia (TIVA) and Volatile Anaesthesia Using Sevoflurane or Desflurane on the Intraoperative Blood Loss During Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 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 utility of Pupillary Dilatation Reflex (PRD) 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, Pupillary Dilatation Reflex (PRD) 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. PRD value >5% reflects increased sensitivity to painful stimulus it constitutes the indication for administration of rescue analgesia intraoperatively.
This study aims at evaluating utility of PRD-directed 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
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 PRD or SE measurement impossible
研究组 & 干预措施
SEVOFLURANE INHALATIONAL ANAESTHESIA
concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE between 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
干预措施: Remifentanil (Drug)
SEVOFLURANE INHALATIONAL ANAESTHESIA
concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE between 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
干预措施: pupillary dilatation reflex (Device)
DESFLURANE INHALATIONAL ANAESTHESIA
concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
干预措施: Remifentanil (Drug)
DESFLURANE INHALATIONAL ANAESTHESIA
concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
干预措施: pupillary dilatation reflex (Device)
TIVA USING PROPOROL
Infusion of propofol will be adjusted at target of SE 40,remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
干预措施: Remifentanil (Drug)
TIVA USING PROPOROL
Infusion of propofol will be adjusted at target of SE 40,remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
干预措施: pupillary dilatation reflex (Device)
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
- heart rate stability intraoperatively(intraoperative assessment)
- PRD-guided pain perception intraoperatively(intraoperative assessment)
- condition of surgical field(intraoperative assessment)
- total consumption of propofol(end of operation assessment)
- total consumption of remifentanil(end of operation assessment)
- concentration of desflurane in end-expiratory gas(intraoperative assessment)
- concentration of sevoflurane in end-expiratory gas(intraoperative assessment)
研究者
Michał Stasiowski
Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
Medical University of Silesia
