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SPI-guided Analgesia During FESS for Intraoperative Blood Loss (FESSSPI)

Primary Purpose

Endoscopic Sinus Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Remifentanil
surgical pleth index
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 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

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 SE measurement impossible
  • necessity of administration of vasoactive drugs

Sites / Locations

  • Medical University of SilesiaRecruiting
  • Medical University of SilesiaRecruiting

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 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

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

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

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
SPI-guided pain perception intraoperatively
The investigators will measure SPI values and adjust infusion speed of remifentanyl, in the case of delta SPI>15 the speed of remifentanyl infusion will accelerate by 50%, intraoperatively, every 1 minute, 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 the concentration 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
January 23, 2022
Sponsor
Medical University of Silesia
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1. Study Identification

Unique Protocol Identification Number
NCT03417180
Brief Title
SPI-guided Analgesia During FESS for Intraoperative Blood Loss
Acronym
FESSSPI
Official Title
Comparative Study of Influence of Surgical Pleth Index Guided Total Intravenous Anaesthesia (TIVA) or 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
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 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 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
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, the Surgical Pleth Index (SPI) 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. SPI>10 or any SPI>50, were proposed to constitute the indication for administration of rescue analgesia intraoperatively. This study aims at evaluating utility of SPI-guided 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
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

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 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
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,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
Arm Title
TIVA USING PROPOROL
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Remifentanil infusion
Intervention Description
a rate of infusion of reminfentanil will be increased by 50% every 5 minutes, until SPI value decreases back to baseline level
Intervention Type
Device
Intervention Name(s)
surgical pleth index
Other Intervention Name(s)
SPI
Intervention Description
every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes
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
SPI-guided pain perception intraoperatively
Description
The investigators will measure SPI values and adjust infusion speed of remifentanyl, in the case of delta SPI>15 the speed of remifentanyl infusion will accelerate by 50%, intraoperatively, every 1 minute, 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 the concentration 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
Gender Based
Yes
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 SE measurement impossible necessity of administration of vasoactive drugs
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 O Jałowiecki, Ph. Dr
Organizational Affiliation
Medical University of Silesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Silesia
City
Sosnowiec
State/Province
Silesia
ZIP/Postal Code
41-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michał J. Stasiowski
Phone
696797922
Ext
0048
Email
mstasiowski.anest@gmail.com
First Name & Middle Initial & Last Name & Degree
Lech Krawczyk, Ph. Dr.
Phone
323682341
Ext
0048
Email
lech.kraw@gmail.com
Facility Name
Medical University of Silesia
City
Sosnowiec
State/Province
Silesia
ZIP/Postal Code
41-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michał J Stasiowski, M.D
Phone
696797922
Ext
0048
Email
mstasiowski.anest@gmail.com
First Name & Middle Initial & Last Name & Degree
Lech Krawczyk, Ph. Dr.
Phone
323682341
Ext
0048
Email
lech.kraw@gmail.com

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
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Results Reference
background
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
background
PubMed Identifier
25032676
Citation
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.
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
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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
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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
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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
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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
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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.
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PubMed Identifier
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Citation
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Citation
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Citation
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SPI-guided Analgesia During FESS for Intraoperative Blood Loss

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