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PRD-guided Analgesia During FESS for Intraoperative Blood Loss (FESSPRD)

Primary Purpose

Endoscopic Sinus Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remifentanil
pupillary dilatation reflex
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endoscopic Sinus Surgery focused on measuring Pupillary Dilatation Reflex (PRD), Intraoperative Blood Loss (IBL), Boezaart Bleeding Scale (BBS), Spectral Entropy (SE), Adequacy of Anaesthesia (AoA), Total Intravenous Anaesthesia (TIVA), Sevoflurane, Desflurane

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    SEVOFLURANE INHALATIONAL ANAESTHESIA

    DESFLURANE INHALATIONAL ANAESTHESIA

    TIVA USING PROPOROL

    Arm Description

    concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE between 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%

    concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%

    Infusion of propofol will be adjusted at target of SE 40,remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    heart rate stability intraoperatively
    the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation
    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
    condition of surgical field
    the surgeon will assess the quality of surgical field using BBS when the operation of FESS
    total consumption of propofol
    The investigators will measure the consumption of propofol intraoperatively
    total consumption of remifentanil
    The investigators will measure the consumption of remifentanyl intraoperatively
    concentration of desflurane in end-expiratory gas
    The investigators will measure theconcentration of desflurane in end-expiratory gas intraoperatively
    concentration of sevoflurane in end-expiratory gas
    The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively

    Full Information

    First Posted
    January 5, 2018
    Last Updated
    October 21, 2020
    Sponsor
    Medical University of Silesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03417206
    Brief Title
    PRD-guided Analgesia During FESS for Intraoperative Blood Loss
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    January 15, 2023 (Anticipated)
    Study Completion Date
    January 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Silesia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endoscopic Sinus Surgery
    Keywords
    Pupillary Dilatation Reflex (PRD), Intraoperative Blood Loss (IBL), Boezaart Bleeding Scale (BBS), Spectral Entropy (SE), Adequacy of Anaesthesia (AoA), Total Intravenous Anaesthesia (TIVA), Sevoflurane, Desflurane

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SEVOFLURANE INHALATIONAL ANAESTHESIA
    Arm Type
    Experimental
    Arm Description
    concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE between 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
    Arm Title
    DESFLURANE INHALATIONAL ANAESTHESIA
    Arm Type
    Experimental
    Arm Description
    concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
    Arm Title
    TIVA USING PROPOROL
    Arm Type
    Experimental
    Arm Description
    Infusion of propofol will be adjusted at target of SE 40,remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Other Intervention Name(s)
    Remifentanil infusion
    Intervention Description
    a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
    Intervention Type
    Device
    Intervention Name(s)
    pupillary dilatation reflex
    Intervention Description
    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%
    Primary Outcome Measure Information:
    Title
    blood loss postoperatively
    Description
    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
    Time Frame
    end of operation,' assessment
    Secondary Outcome Measure Information:
    Title
    heart rate stability intraoperatively
    Description
    the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation
    Time Frame
    intraoperative assessment
    Title
    PRD-guided pain perception intraoperatively
    Description
    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
    Time Frame
    intraoperative assessment
    Title
    condition of surgical field
    Description
    the surgeon will assess the quality of surgical field using BBS when the operation of FESS
    Time Frame
    intraoperative assessment
    Title
    total consumption of propofol
    Description
    The investigators will measure the consumption of propofol intraoperatively
    Time Frame
    end of operation assessment
    Title
    total consumption of remifentanil
    Description
    The investigators will measure the consumption of remifentanyl intraoperatively
    Time Frame
    end of operation assessment
    Title
    concentration of desflurane in end-expiratory gas
    Description
    The investigators will measure theconcentration of desflurane in end-expiratory gas intraoperatively
    Time Frame
    intraoperative assessment
    Title
    concentration of sevoflurane in end-expiratory gas
    Description
    The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively
    Time Frame
    intraoperative assessment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michał J Stasiowski, MD
    Phone
    696797922
    Ext
    0048
    Email
    mstasiowski.anest@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lech Krawczyk, Ph. Dr
    Phone
    323682341
    Ext
    0048
    Email
    lech.kraw@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Przemysław Jałowiecki, Ph. Dr
    Organizational Affiliation
    Medical University of Silesia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    article in Laryngoscope in 2022, case reports
    IPD Sharing Time Frame
    starting 6 months after publication
    Citations:
    PubMed Identifier
    17376252
    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. doi: 10.1017/S0265021506002080. Epub 2007 Mar 12.
    Results Reference
    result
    PubMed Identifier
    15711683
    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.
    Results Reference
    result
    PubMed Identifier
    27275059
    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.
    Results Reference
    result
    PubMed Identifier
    24282774
    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 Sep 1.
    Results Reference
    result
    PubMed Identifier
    24052249
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    26030032
    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 anaesthesia. Rhinology. 2015 Jun;53(2):107-15. doi: 10.4193/Rhino14.185.
    Results Reference
    result
    PubMed Identifier
    21786531
    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. Polish.
    Results Reference
    result
    PubMed Identifier
    22185726
    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):e208-11. doi: 10.2500/ajra.2011.25.3701.
    Results Reference
    result
    PubMed Identifier
    23193905
    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 quantification. Ann Otol Rhinol Laryngol. 2012 Nov;121(11):725-32. doi: 10.1177/000348941212101105.
    Results Reference
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    PubMed Identifier
    17959973
    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. 2007 Nov;105(5):1404-9, table of contents. doi: 10.1213/01.ane.0000282781.56025.52.
    Results Reference
    result

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    PRD-guided Analgesia During FESS for Intraoperative Blood Loss

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