SPI-guided Analgesia During FESS for Intraoperative Blood Loss

Endoscopic Sinus Surgery Clinical Trial

— FESSSPI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03417180
• Other study ID #: SilesianMUKOAiIT10
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 15, 2023

Study information

• Verified date: January 2022
• Source: Medical University of Silesia
• Contact: Michal J Stasiowski, MD
• Phone: 696797922
• Email: mstasiowski.anest[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Sinus Surgery
• Hemorrhage

Intervention

Drug:
• Remifentanil
a rate of infusion of reminfentanil will be increased by 50% every 5 minutes, until SPI value decreases back to baseline level

Device:
• surgical pleth index
every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes

Locations

Country	Name	City	State
Poland	Medical University of Silesia	Sosnowiec	Silesia
Poland	Medical University of Silesia	Sosnowiec	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (12)

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 Cl — View Citation

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. — View Citation

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. Epub 2007 Mar 12. — View Citation

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 anaes — View Citation

Cardesín 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/s00405-01 — View Citation

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. Review. — View Citation

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. Review. Polish. — View Citation

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 quantifi — View Citation

Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 — View Citation

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 — View Citation

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):e — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	heart rate stability intraoperatively	the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation	intraoperative assessment
Secondary	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
Secondary	condition of surgical field	the surgeon will assess the quality of surgical field using BBS when the operation of FESS	intraoperative assessment
Secondary	total consumption of propofol	The investigators will measure the consumption of propofol intraoperatively	end of operation assessment
Secondary	total consumption of remifentanil	The investigators will measure the consumption of remifentanyl intraoperatively	end of operation assessment
Secondary	concentration of desflurane in end-expiratory gas	The investigators will measure the concentration of desflurane in end-expiratory gas intraoperatively	intraoperative assessment
Secondary	concentration of sevoflurane in end-expiratory gas	The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively	intraoperative assessment