SPI-guided Analgesia During FESS for Intraoperative Blood Loss

NCT03417180 | Unknown

• 1 other identifier: SilesianMUKOAiIT10
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Endoscopic Sinus Surgery

Keywords

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

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

  intraoperative assessment

• SPI-guided pain perception intraoperatively

  intraoperative assessment

• condition of surgical field

  intraoperative assessment

• total consumption of propofol

  end of operation assessment

• total consumption of remifentanil

  end of operation assessment

Study Arms (3)

SEVOFLURANE INHALATIONAL ANAESTHESIA

EXPERIMENTAL

concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanil 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% every 5 minutes until SPI value decreases back to baseline value

Drug: Remifentanil; Device: surgical pleth index

DESFLURANE INHALATIONAL ANAESTHESIA

EXPERIMENTAL

concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40,remifentanil 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% every 5 minutes until SPI value decreases back to baseline value

Drug: Remifentanil; Device: surgical pleth index

TIVA USING PROPOROL

EXPERIMENTAL

infusion of propofol will be adjusted at target of SE 40, remifentanyl infusion 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% every 5 minutes until SPI value decreases back to baseline value

Drug: Remifentanil; Device: surgical pleth index

Interventions

Remifentanil DRUG

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

Also known as: Remifentanil infusion

DESFLURANE INHALATIONAL ANAESTHESIA; SEVOFLURANE INHALATIONAL ANAESTHESIA; TIVA USING PROPOROL

surgical pleth index DEVICE

every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes

Also known as: SPI

DESFLURANE INHALATIONAL ANAESTHESIA; SEVOFLURANE INHALATIONAL ANAESTHESIA; TIVA USING PROPOROL

Eligibility Criteria

• Age: 18 Years - 80 Years
• 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 general 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 SE measurement impossible
• necessity of administration of vasoactive drugs

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (2)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

RECRUITING

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Jul 17.

  PMID: 25032676 RESULT

• 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 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. 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 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

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

Central Study Contacts

Michał J Stasiowski, MD

CONTACT

696797922; mstasiowski.anest@gmail.com

Lech Krawczyk, Ph. Dr

CONTACT

323682341; lech.kraw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• 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: January 5, 2018
• First Posted: January 31, 2018
• Study Start: September 1, 2018
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

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

Locations

PL (2)