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

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ClinicalTrials.gov Identifier: NCT03417206
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Michał Stasiowski, Medical University of Silesia

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

Condition or disease Intervention/treatment Phase
Endoscopic Sinus Surgery Drug: Remifentanil Device: pupillary dilatation reflex Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: 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%
Drug: Remifentanil
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
Other Name: Remifentanil infusion

Device: 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%

Experimental: 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%
Drug: Remifentanil
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
Other Name: Remifentanil infusion

Device: 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%

Experimental: 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%
Drug: Remifentanil
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
Other Name: Remifentanil infusion

Device: 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%




Primary Outcome Measures :
  1. blood loss postoperatively [ Time Frame: end of operation,' assessment ]
    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 :
  1. heart rate stability intraoperatively [ Time Frame: intraoperative assessment ]
    the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation

  2. PRD-guided pain perception intraoperatively [ Time Frame: intraoperative assessment ]
    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

  3. condition of surgical field [ Time Frame: intraoperative assessment ]
    the surgeon will assess the quality of surgical field using BBS when the operation of FESS

  4. total consumption of propofol [ Time Frame: end of operation assessment ]
    The investigators will measure the consumption of propofol intraoperatively

  5. total consumption of remifentanil [ Time Frame: end of operation assessment ]
    The investigators will measure the consumption of remifentanyl intraoperatively

  6. concentration of desflurane in end-expiratory gas [ Time Frame: intraoperative assessment ]
    The investigators will measure theconcentration of desflurane in end-expiratory gas intraoperatively

  7. concentration of sevoflurane in end-expiratory gas [ Time Frame: intraoperative assessment ]
    The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417206


Contacts
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Contact: Michał J Stasiowski, MD 696797922 ext 0048 mstasiowski.anest@gmail.com
Contact: Lech Krawczyk, Ph. Dr 323682341 ext 0048 lech.kraw@gmail.com

Sponsors and Collaborators
Medical University of Silesia
Investigators
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Principal Investigator: Przemysław Jałowiecki, Ph. Dr Medical University of Silesia
Publications of Results:

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Responsible Party: Michał Stasiowski, Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03417206    
Other Study ID Numbers: SilesianMUKOAiIT9
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: article in Laryngoscope in 2022, case reports
Supporting Materials: Informed Consent Form (ICF)
Time Frame: starting 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michał Stasiowski, Medical University of Silesia:
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
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents