Endoscopic Sinus Surgery
Conditions
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
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.
Interventions
DRUGRemifentanil
a rate of infusion of reminfentanil will be increased by 50% every 5 minutes, until SPI value decreases back to baseline level
DEVICEsurgical pleth index
every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes
Sponsors
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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 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
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 |
|---|---|---|
| heart rate stability intraoperatively | intraoperative assessment | the investigators will measure heart rate during TIVAevery 5 minutes 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 |
| condition of surgical field | intraoperative assessment | the surgeon will assess the quality of surgical field using BBS when the operation of FESS |
| total consumption of remifentanil | end of operation assessment | The investigators will measure the consumption of remifentanyl intraoperatively |
| concentration of desflurane in end-expiratory gas | intraoperative assessment | The investigators will measure the concentration of desflurane in end-expiratory gas intraoperatively |
| concentration of sevoflurane in end-expiratory gas | intraoperative assessment | The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively |
| total consumption of propofol | end of operation assessment | The investigators will measure the consumption of propofol intraoperatively |
Countries
Poland
Contacts
Primary ContactMichał J Stasiowski, MD
Backup ContactLech Krawczyk, Ph. Dr
Outcome results
None listed