- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03417206
PRD-guided Analgesia During FESS for Intraoperative Blood Loss (FESSPRD)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michał J Stasiowski, MD
- Phone Number: 0048 696797922
- Email: mstasiowski.anest@gmail.com
Study Contact Backup
- Name: Lech Krawczyk, Ph. Dr
- Phone Number: 0048 323682341
- Email: lech.kraw@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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%
|
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
Other Names:
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%
|
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
Other Names:
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%
|
a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
Other Names:
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%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
end of operation,' assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
intraoperative assessment
|
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
|
intraoperative assessment
|
condition of surgical field
Time Frame: intraoperative assessment
|
the surgeon will assess the quality of surgical field using BBS when the operation of FESS
|
intraoperative assessment
|
total consumption of propofol
Time Frame: end of operation assessment
|
The investigators will measure the consumption of propofol intraoperatively
|
end of operation assessment
|
total consumption of remifentanil
Time Frame: end of operation assessment
|
The investigators will measure the consumption of remifentanyl intraoperatively
|
end of operation assessment
|
concentration of desflurane in end-expiratory gas
Time Frame: intraoperative assessment
|
The investigators will measure theconcentration of desflurane in end-expiratory gas intraoperatively
|
intraoperative assessment
|
concentration of sevoflurane in end-expiratory gas
Time Frame: intraoperative assessment
|
The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively
|
intraoperative assessment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Przemysław Jałowiecki, Ph. Dr, Medical University of Silesia
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SilesianMUKOAiIT9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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