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Completed

NCT Number: NCT03389763

SPI-guided vs PRD-guided Analgesia During FESS for Intraoperative Blood Loss

The aim of this randomized trial is to assess the efficacy of analgesia , compare the utility of Pupillary Dilatation Reflex (PRD), Surgical Pleth Index (SPI) for monitoring pain perception intraoperatively and their influence on intraoperative blood loss, quality of surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing functional sinus surgery (FESS)

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

About this study

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) and Pupillary Dilatation Reflex (PRD) were 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 as well as delta SPI>10 or any SPI>50, and they constitute the indication for administration of rescue analgesia intraoperatively.

This study aims at evaluating utility of SPI-directed analgesia or PRD-directed analgesia or Boezaart scale-directed analgesia using remifentanil on the intraoperative blood loss, haemodynamic stability and time duration of surgery.

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 literature provides conflicting findings in this area.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written consent to participate in the study
  • written consent to undergo functional endoscopic sinus surgery under total intravenous 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

Treatment and study plan

Remifentanil

Drug

a rate of infusion will be increased by 50% every 5 minutes

Other names: Remifentanil infusion

Primary outcomes

  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 outcomes

  1. heart rate stability intraoperatively

    Time frame: end of operation,' assessment

    the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation

  2. hemodynamic stability intraoperatively

    Time frame: intraoperative assessment

    the investigators will measure blood pressure every 5 minutes during TIVA, every 5 minutes up to the end of the operation

  3. 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

  4. SPI-guided pain perception intraoperatively

    Time frame: intraoperative assessment

    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

  5. condition of surgical field

    Time frame: intraoperative assessment

    the surgeon will assess the quality of surgical field using BBS when the operation of FESS is performed, every 5 minutes or at any change of BBS form the beginning till the end of surgery, up to the end of the operation

  6. total consumption of propofol

    Time frame: end of operation assessment

    The investigators will measure the consumption of propofol intraoperatively

  7. total consumption of remifentanil

    Time frame: end of operation assessment

    The investigators will measure the consumption of remifentanyl intraoperatively

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Comparative Study of Influence of Different Techniques of Remifentanil Titration During Functional Endoscopic Sinus Surgery Under Total Intravenous Anaesthesia (TIVA)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2018
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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