Comparative Study of Influence of Different Techniques of Remifentanil Titration During Functional Endoscopic Sinus Surgery Under Total Intravenous Anaesthesia (TIVA)
Overview
- Phase
- Not Applicable
- Intervention
- Remifentanil
- Conditions
- Endoscopic Sinus Surgery
- Sponsor
- Medical University of Silesia
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- blood loss postoperatively
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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)
Detailed Description
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.
Investigators
Michał Stasiowski
Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
Medical University of Silesia
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •age under 18 years old
- •allergy to propofol
- •pregnancy
- •any anatomical malformation making PRD or SE measurement impossible
Arms & Interventions
SPI-guided remifentanyl
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%
Intervention: Remifentanil
PRD-guided remifentanyl
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%
Intervention: Remifentanil
BBS-guided remifentanyl
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%
Intervention: Remifentanil
Outcomes
Primary Outcomes
blood loss postoperatively
Time Frame: 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
Secondary Outcomes
- 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)