SPI-guided Analgesia During FESS for Intraoperative Blood Loss

Not Applicable

• Conditions: Endoscopic Sinus Surgery
• Interventions: Drug: Remifentanil; Device: surgical pleth index

• Registration Number: NCT03417180
• Lead Sponsor: Medical University of Silesia

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.

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-09-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-23
• Last Update Posted: 2022-01-25
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

• age under 18 years old
• allergy to propofol
• pregnancy
• any anatomical malformation making SE measurement impossible
• necessity of administration of vasoactive drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEVOFLURANE INHALATIONAL ANAESTHESIA	surgical pleth index	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
TIVA USING PROPOROL	surgical pleth index	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
DESFLURANE INHALATIONAL ANAESTHESIA	surgical pleth index	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
SEVOFLURANE INHALATIONAL ANAESTHESIA	Remifentanil	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
DESFLURANE INHALATIONAL ANAESTHESIA	Remifentanil	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
TIVA USING PROPOROL	Remifentanil	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

Primary Outcome Measures

Name	Time	Method
blood loss postoperatively	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 Outcome Measures

Name	Time	Method
total consumption of remifentanil	end of operation assessment	The investigators will measure the consumption of remifentanyl intraoperatively
SPI-guided pain perception intraoperatively	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
condition of surgical field	intraoperative assessment	the surgeon will assess the quality of surgical field using BBS when the operation of FESS
total consumption of propofol	end of operation assessment	The investigators will measure the consumption of propofol intraoperatively
concentration of desflurane in end-expiratory gas	intraoperative assessment	The investigators will measure the concentration of desflurane in end-expiratory gas intraoperatively
concentration of sevoflurane in end-expiratory gas	intraoperative assessment	The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively
heart rate stability intraoperatively	intraoperative assessment	the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation

Trial Locations

Locations (1)

Medical University of Silesia; 🇵🇱 Sosnowiec, Silesia, Poland