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

NCT03389763 | Completed DMC

• 1 other identifier: SilesianMUKOAiIT3
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Endoscopic Sinus Surgery

Keywords

Surgical Pleth Index (SPI); Pupillary Dilatation Reflex (PRD); Intraoperative Blood Loss (IBL); Boezaart Bleeding Scale (BBS); Spectral Entropy (SE); Adequacy of Anaesthesia (AoA); Total Intravenous Anaesthesia (TIVA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• heart rate stability intraoperatively

  end of operation,' assessment

• hemodynamic stability intraoperatively

  intraoperative assessment

• PRD-guided pain perception intraoperatively

  intraoperative assessment

• SPI-guided pain perception intraoperatively

  intraoperative assessment

• condition of surgical field

  intraoperative assessment

Study Arms (3)

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%

Drug: Remifentanil

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%

Drug: Remifentanil

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%

Drug: Remifentanil

Interventions

Remifentanil DRUG

a rate of infusion will be increased by 50% every 5 minutes

Also known as: Remifentanil infusion

BBS-guided remifentanyl; PRD-guided remifentanyl; SPI-guided remifentanyl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age under 18 years old
• allergy to propofol
• pregnancy
• any anatomical malformation making PRD or SE measurement impossible

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Related Publications (19)

• 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.

  PMID: 27275059 BACKGROUND

• 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.

  PMID: 24052249 BACKGROUND

• 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.

  PMID: 21253373 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.

  PMID: 17376252 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.

  PMID: 15711683 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.

  PMID: 24282774 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.

  PMID: 26030032 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.

  PMID: 21786531 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.

  PMID: 22185726 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.

  PMID: 23843351 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.

  PMID: 23193905 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.

  PMID: 8214320 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.

  PMID: 17959973 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.

  PMID: 15785115 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.

  PMID: 25885986 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.

  PMID: 25730338 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.

  PMID: 23883683 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.

  PMID: 23910160 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.

  PMID: 22446982 RESULT

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Przemysław O Jałowiecki, Ph.Dr

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: January 4, 2018
• Study Start: June 1, 2016
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: starting 6 months after publication

Locations

PL (1)