SPI-guided vs PRD-guided Analgesia During FESS for Intraoperative Blood Loss

Endoscopic Sinus Surgery Clinical Trial

Official title:

Comparative Study of Influence of Different Techniques of Remifentanil Titration During Functional Endoscopic Sinus Surgery Under Total Intravenous Anaesthesia (TIVA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389763
• Other study ID #: SilesianMUKOAiIT3
• Status: Completed
• Phase: N/A
• First received: September 6, 2017
• Last updated: January 24, 2018
• Start date: June 1, 2016
• Est. completion date: January 15, 2018

Study information

• Verified date: January 2018
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• 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 total intravenous 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

Intervention

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

Locations

Country	Name	City	State
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 (19)

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: 1 — View Citation

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. — 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. — 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/s00405-013-2700-0. Epub 2013 Sep 20. — 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

Guglielminotti J, Grillot N, Paule M, Mentré 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. — View Citation

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. Epub 2005 Mar 22. — 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

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 wit — 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

Paulus J, Roquilly A, Beloeil H, Théraud 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. — View Citation

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) — 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

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 De — View Citation

* Note: There are 19 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	end of operation,' assessment
Secondary	hemodynamic stability intraoperatively	the investigators will measure blood pressure every 5 minutes during TIVA, every 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	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 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
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