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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPI-guided remifentanyl | Experimental | 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% |
|
| PRD-guided remifentanyl | Experimental | 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% |
|
| BBS-guided remifentanyl | Experimental | 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% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | a rate of infusion will be increased by 50% every 5 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood loss postoperatively | 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 | end of operation,' assessment |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate stability intraoperatively | the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation | end of operation,' assessment |
| hemodynamic stability intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Przemysław O Jałowiecki, Ph.Dr | Medical University of Silesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Silesia | Sosnowiec | Silesian Voivodeship | 41-200 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27275059 | Background | Bhat Pai RV, Badiger S, Sachidananda R, Basappaji SM, Shanbhag R, Rao R. Comparison of surgical conditions following premedication with oral clonidine versus oral diazepam for endoscopic sinus surgery: A randomized, double-blinded study. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):250-6. doi: 10.4103/0970-9185.182112. | |
| 24052249 |
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article in Laryngoscope in 2018, case reports
starting 6 months after publication
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
the investigators will measure blood pressure every 5 minutes during TIVA, every 5 minutes up to the end of the operation
| intraoperative assessment |
| PRD-guided pain perception intraoperatively | 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 | intraoperative assessment |
| SPI-guided pain perception intraoperatively | 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 | intraoperative assessment |
| condition of surgical field | 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 | intraoperative assessment |
| total consumption of propofol | The investigators will measure the consumption of propofol intraoperatively | end of operation assessment |
| total consumption of remifentanil | The investigators will measure the consumption of remifentanyl intraoperatively | end of operation assessment |
| Cardesin A, Pontes C, Rosell R, Escamilla Y, Marco J, Escobar MJ, Bernal-Sprekelsen M. Hypotensive anaesthesia and bleeding during endoscopic sinus surgery: an observational study. Eur Arch Otorhinolaryngol. 2014 Jun;271(6):1505-11. doi: 10.1007/s00405-013-2700-0. Epub 2013 Sep 20. |
| 21253373 | Result | Yoo HS, Han JH, Park SW, Kim KS. Comparison of surgical condition in endoscopic sinus surgery using remifentanil combined with propofol, sevoflurane, or desflurane. Korean J Anesthesiol. 2010 Dec;59(6):377-82. doi: 10.4097/kjae.2010.59.6.377. Epub 2010 Dec 31. |
| 17376252 | Result | Cafiero T, Cavallo LM, Frangiosa A, Burrelli R, Gargiulo G, Cappabianca P, de Divitiis E. Clinical comparison of remifentanil-sevoflurane vs. remifentanil-propofol for endoscopic endonasal transphenoidal surgery. Eur J Anaesthesiol. 2007 May;24(5):441-6. doi: 10.1017/S0265021506002080. Epub 2007 Mar 12. |
| 15711683 | Result | Sivaci R, Yilmaz MD, Balci C, Erincler T, Unlu H. Comparison of propofol and sevoflurane anesthesia by means of blood loss during endoscopic sinus surgery. Saudi Med J. 2004 Dec;25(12):1995-8. |
| 24282774 | Result | Marzban S, Haddadi S, Mahmoudi Nia H, Heidarzadeh A, Nemati S, Naderi Nabi B. Comparison of surgical conditions during propofol or isoflurane anesthesia for endoscopic sinus surgery. Anesth Pain Med. 2013 Sep;3(2):234-8. doi: 10.5812/aapm.9891. Epub 2013 Sep 1. |
| 26030032 | Result | Cardesin A, Pontes C, Rosell R, Escamilla Y, Marco J, Escobar MJ, Bernal-Sprekelsen M. A randomised double blind clinical trial to compare surgical field bleeding during endoscopic sinus surgery with clonidine-based or remifentanil-based hypotensive anaesthesia. Rhinology. 2015 Jun;53(2):107-15. doi: 10.4193/Rhino14.185. |
| 21786531 | Result | Drozdowski A, Sieskiewicz A, Siemiatkowski A. [Reduction of intraoperative bleeding during functional endoscopic sinus surgery]. Anestezjol Intens Ter. 2011 Jan-Mar;43(1):45-50. Polish. |
| 22185726 | Result | Shen PH, Weitzel EK, Lai JT, Wormald PJ, Ho CS. Intravenous esmolol infusion improves surgical fields during sevoflurane-anesthetized endoscopic sinus surgery: a double-blind, randomized, placebo-controlled trial. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e208-11. doi: 10.2500/ajra.2011.25.3701. |
| 23843351 | Result | DeConde AS, Thompson CF, Wu EC, Suh JD. Systematic review and meta-analysis of total intravenous anesthesia and endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Oct;3(10):848-54. doi: 10.1002/alr.21196. Epub 2013 Jul 10. |
| 23193905 | Result | Gomez-Rivera F, Cattano D, Ramaswamy U, Patel CB, Altamirano A, Man LX, Luong A, Chen Z, Citardi MJ, Fakhri S. Pilot study comparing total intravenous anesthesia to inhalational anesthesia in endoscopic sinus surgery: novel approach of blood flow quantification. Ann Otol Rhinol Laryngol. 2012 Nov;121(11):725-32. doi: 10.1177/000348941212101105. |
| 8214320 | Result | Blackwell KE, Ross DA, Kapur P, Calcaterra TC. Propofol for maintenance of general anesthesia: a technique to limit blood loss during endoscopic sinus surgery. Am J Otolaryngol. 1993 Jul-Aug;14(4):262-6. doi: 10.1016/0196-0709(93)90072-f. |
| 17959973 | Result | Nekhendzy V, Lemmens HJ, Vaughan WC, Hepworth EJ, Chiu AG, Church CA, Brock-Utne JG. The effect of deliberate hypercapnia and hypocapnia on intraoperative blood loss and quality of surgical field during functional endoscopic sinus surgery. Anesth Analg. 2007 Nov;105(5):1404-9, table of contents. doi: 10.1213/01.ane.0000282781.56025.52. |
| 15785115 | Result | Manola M, De Luca E, Moscillo L, Mastella A. Using remifentanil and sufentanil in functional endoscopic sinus surgery to improve surgical conditions. ORL J Otorhinolaryngol Relat Spec. 2005;67(2):83-6. doi: 10.1159/000084576. Epub 2005 Mar 22. |
| 25885986 | Result | Puthenveettil N, Rajan S, Kumar L, Nair SG. A comparison of effects of oral premedication with clonidine and metoprolol on intraoperative hemodynamics and surgical conditions during functional endoscopic sinus surgery. Anesth Essays Res. 2013 Sep-Dec;7(3):371-5. doi: 10.4103/0259-1162.123244. |
| 25730338 | Result | Guglielminotti J, Grillot N, Paule M, Mentre F, Servin F, Montravers P, Longrois D. Prediction of movement to surgical stimulation by the pupillary dilatation reflex amplitude evoked by a standardized noxious test. Anesthesiology. 2015 May;122(5):985-93. doi: 10.1097/ALN.0000000000000624. |
| 23883683 | Result | Paulus J, Roquilly A, Beloeil H, Theraud J, Asehnoune K, Lejus C. Pupillary reflex measurement predicts insufficient analgesia before endotracheal suctioning in critically ill patients. Crit Care. 2013 Jul 24;17(4):R161. doi: 10.1186/cc12840. |
| 23910160 | Result | Migeon A, Desgranges FP, Chassard D, Blaise BJ, De Queiroz M, Stewart A, Cejka JC, Combet S, Rhondali O. Pupillary reflex dilatation and analgesia nociception index monitoring to assess the effectiveness of regional anesthesia in children anesthetised with sevoflurane. Paediatr Anaesth. 2013 Dec;23(12):1160-5. doi: 10.1111/pan.12243. Epub 2013 Aug 2. |
| 22446982 | Result | Aissou M, Snauwaert A, Dupuis C, Atchabahian A, Aubrun F, Beaussier M. Objective assessment of the immediate postoperative analgesia using pupillary reflex measurement: a prospective and observational study. Anesthesiology. 2012 May;116(5):1006-12. doi: 10.1097/ALN.0b013e318251d1fb. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |