Endoscopic Sinus Surgery
Conditions
Keywords
Surgical Pleth Index (SPI), Pupillary Dilatation Reflex (PRD), Intraoperative Blood Loss (IBL), Boezaart Bleeding Scale (BBS), Spectral Entropy (SE), Adequacy of Anaesthesia (AoA), Total Intravenous Anaesthesia (TIVA)
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.
Interventions
DRUGRemifentanil
a rate of infusion will be increased by 50% every 5 minutes
Sponsors
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood loss postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic stability intraoperatively | intraoperative assessment | the investigators will measure blood pressure every 5 minutes during TIVA, every 5 minutes up to the end of the operation |
| PRD-guided pain perception intraoperatively | intraoperative assessment | The investigators will measure PRD value and adjust infusion speed of remifentanyl, in the case of PRD value \>5% the speed of remifentanyl infusion will accelerate by 50%, intraoperatively, every 15 minutes or at any change of BBS, up to the end of the operation |
| SPI-guided pain perception intraoperatively | intraoperative assessment | The investigators will measure SPI values and adjust infusion speed of remifentanyl, in the case of delta SPI\>15 the speed of remifentanyl infusion will accelerate by 50%, intraoperatively, every 1 minute, up to the end of the operation |
| heart rate stability intraoperatively | end of operation,' assessment | the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation |
| total consumption of propofol | end of operation assessment | The investigators will measure the consumption of propofol intraoperatively |
| total consumption of remifentanil | end of operation assessment | The investigators will measure the consumption of remifentanyl intraoperatively |
| condition of surgical field | intraoperative assessment | the surgeon will assess the quality of surgical field using BBS when the operation of FESS is performed, every 5 minutes or at any change of BBS form the beginning till the end of surgery, up to the end of the operation |
Countries
Poland
Outcome results
None listed