Clinical trial NCT03417180: SPI-guided Analgesia During FESS for Intraoperative Blood Loss
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Sinus Surgery
Keywords: Surgical Pleth Index (SPI)
Intraoperative Blood Loss (IBL)
Boezaart Bleeding Scale (BBS)
Spectral Entropy (SE)
Adequacy of Anaesthesia (AoA)
Total Intravenous Anaesthesia (TIVA)
Sevoflurane
Desflurane
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 120
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: PREVENTION

Brief summary: 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

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) 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* age under 18 years old
* allergy to propofol
* pregnancy
* any anatomical malformation making SE measurement impossible
* necessity of administration of vasoactive drugs

Primary outcomes:
measure: blood loss postoperatively
timeFrame: end of operation,' assessment
Secondary outcomes:
measure: heart rate stability 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
measure: concentration of desflurane in end-expiratory gas
timeFrame: intraoperative assessment
measure: concentration of sevoflurane in end-expiratory gas
timeFrame: intraoperative assessment
Other outcomes:
Locations:
city: Sosnowiec
country: Poland
facility: Medical University of Silesia
state: Silesia
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
References:
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