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Clinical Trials/NCT03417180
NCT03417180
Unknown
Not Applicable

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

Medical University of Silesia1 site in 1 country120 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Remifentanil
Conditions
Endoscopic Sinus Surgery
Sponsor
Medical University of Silesia
Enrollment
120
Locations
1
Primary Endpoint
blood loss postoperatively
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
July 15, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michał Stasiowski

Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy

Medical University of Silesia

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

Arms & Interventions

SEVOFLURANE INHALATIONAL ANAESTHESIA

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

Intervention: Remifentanil

SEVOFLURANE INHALATIONAL ANAESTHESIA

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

Intervention: surgical pleth index

DESFLURANE INHALATIONAL ANAESTHESIA

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

Intervention: Remifentanil

DESFLURANE INHALATIONAL ANAESTHESIA

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

Intervention: surgical pleth index

TIVA USING PROPOROL

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: Remifentanil

TIVA USING PROPOROL

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: surgical pleth index

Outcomes

Primary Outcomes

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 Outcomes

  • total consumption of remifentanil(end of operation assessment)
  • SPI-guided pain perception intraoperatively(intraoperative assessment)
  • condition of surgical field(intraoperative assessment)
  • total consumption of propofol(end of operation assessment)
  • concentration of desflurane in end-expiratory gas(intraoperative assessment)
  • concentration of sevoflurane in end-expiratory gas(intraoperative assessment)
  • heart rate stability intraoperatively(intraoperative assessment)

Study Sites (1)

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