PRD-guided Analgesia During FESS for Intraoperative Blood Loss
NCT ID: NCT03417206
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2021-09-01
2023-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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SEVOFLURANE INHALATIONAL ANAESTHESIA
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%
Remifentanil
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
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%
DESFLURANE INHALATIONAL ANAESTHESIA
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%
Remifentanil
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
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%
TIVA USING PROPOROL
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%
Remifentanil
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
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%
Interventions
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Remifentanil
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
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%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* written consent to undergo functional endoscopic sinus surgery under general anaesthesia
* ASA (American Society of Anesthesiologists) I-III
Exclusion Criteria
* allergy to propofol
* pregnancy
* any anatomical malformation making PRD or SE measurement impossible
18 Years
80 Years
ALL
No
Sponsors
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Medical University of Silesia
OTHER
Responsible Party
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Michał Stasiowski
Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
Principal Investigators
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Przemysław Jałowiecki, Ph. Dr
Role: PRINCIPAL_INVESTIGATOR
Medical University of Silesia
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SilesianMUKOAiIT9
Identifier Type: -
Identifier Source: org_study_id
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