PRD-guided Analgesia During FESS for Intraoperative Blood Loss

Endoscopic Sinus Surgery Clinical Trial

— FESSPRD  

Official title:

Comparative Study of Influence of Total Intravenous Anaesthesia (TIVA) and Volatile Anaesthesia Using Sevoflurane or Desflurane on the Intraoperative Blood Loss During Functional Endoscopic Sinus Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03417206
• Other study ID #: SilesianMUKOAiIT9
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: October 2020
• 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 Pupillary Dilatation Reflex (PRD) 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, Pupillary Dilatation Reflex (PRD) 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. PRD value >5% reflects increased sensitivity to painful stimulus it constitutes the indication for administration of rescue analgesia intraoperatively.

This study aims at evaluating utility of PRD-directed 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: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 15, 2023
• Est. primary completion date: January 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 PRD or SE measurement impossible

Related Conditions & MeSH terms

• Endoscopic Sinus Surgery
• Hemorrhage

Intervention

Drug:
• Remifentanil
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%

Device:
• pupillary dilatation reflex
PRD value will me measured before the start of FESS after 5 minutes of remifentanyl infusion, when PRD sensitivity > 5% , infusion of remifentanyl will be increased by 50% until PRD sensitivity <5% and FESS will be started ; intraoperatively infusion of remifentanyl will be increased by 50% until PRD sensitivity <5%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

References & Publications (10)

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

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. — 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

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

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

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. 2 — 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

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	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
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 theconcentration 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