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

January 24, 2018 updated by: Michał Stasiowski, Medical University of Silesia

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

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)

Study Overview

Status

Completed

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, 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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Silesia
      • Sosnowiec, Silesia, Poland, 41-200
        • Medical University of Silesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPI-guided remifentanyl
remifentanyl solution 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%
Drug: Remifentanil
a rate of infusion will be increased by 50% every 5 minutes
Other Names:
  • Remifentanil infusion
Experimental: PRD-guided remifentanyl
solution remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, PRD measurement every 15 minutes; when PRD>5% infusion speed of remifentanyl will be increased by 50%
Drug: Remifentanil
a rate of infusion will be increased by 50% every 5 minutes
Other Names:
  • Remifentanil infusion
Experimental: BBS-guided remifentanyl
BBS assessment every 5 minutes, solution remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute; when BBS>2, infusion speed of remifentanyl will be increased by 50%
Drug: Remifentanil
a rate of infusion will be increased by 50% every 5 minutes
Other Names:
  • Remifentanil infusion

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
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
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
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
end of operation,' assessment
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
intraoperative assessment
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
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 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
intraoperative assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Investigators

  • Principal Investigator: Przemysław O Jałowiecki, Ph.Dr, Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

January 15, 2018

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SilesianMUKOAiIT3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

article in Laryngoscope in 2018, case reports

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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