Clinical trial NCT03389763: SPI-guided vs PRD-guided Analgesia During FESS for Intraoperative Blood Loss
Official title: Comparative Study of Influence of Different Techniques of Remifentanil Titration During Functional Endoscopic Sinus Surgery Under Total Intravenous Anaesthesia (TIVA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Sinus Surgery
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)
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: blood loss postoperatively
timeFrame: end of operation,' assessment
Secondary outcomes:
measure: heart rate stability intraoperatively
timeFrame: end of operation,' assessment
measure: hemodynamic stability intraoperatively
timeFrame: intraoperative assessment
measure: PRD-guided pain perception intraoperatively
timeFrame: intraoperative assessment
measure: SPI-guided pain perception intraoperatively
timeFrame: intraoperative assessment
measure: condition of surgical field
timeFrame: intraoperative assessment
measure: total consumption of propofol
timeFrame: end of operation assessment
measure: total consumption of remifentanil
timeFrame: end of operation assessment
Other outcomes:
Locations:
city: Sosnowiec
country: Poland
facility: Medical University of Silesia
state: Silesia
Study officials:
affiliation: Medical University of Silesia
name: Przemysław O Jałowiecki, Ph.Dr
role: PRINCIPAL_INVESTIGATOR
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