SPI-guided Analgesia During FESS for Intraoperative Blood Loss (FESSSPI)
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| ClinicalTrials.gov Identifier: NCT03417180 |
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Recruitment Status :
Recruiting
First Posted : January 31, 2018
Last Update Posted : January 25, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Endoscopic Sinus Surgery | Drug: Remifentanil Device: surgical pleth index | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | 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 |
| Actual Study Start Date : | September 1, 2018 |
| Estimated Primary Completion Date : | July 15, 2023 |
| Estimated Study Completion Date : | July 15, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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
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Drug: Remifentanil
a rate of infusion of reminfentanil will be increased by 50% every 5 minutes, until SPI value decreases back to baseline level
Other Name: Remifentanil infusion Device: surgical pleth index every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes
Other Name: SPI |
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Experimental: 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
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Drug: Remifentanil
a rate of infusion of reminfentanil will be increased by 50% every 5 minutes, until SPI value decreases back to baseline level
Other Name: Remifentanil infusion Device: surgical pleth index every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes
Other Name: SPI |
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Experimental: 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
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Drug: Remifentanil
a rate of infusion of reminfentanil will be increased by 50% every 5 minutes, until SPI value decreases back to baseline level
Other Name: Remifentanil infusion Device: surgical pleth index every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes
Other Name: SPI |
- 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
- 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
- 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
- condition of surgical field [ Time Frame: intraoperative assessment ]the surgeon will assess the quality of surgical field using BBS when the operation of FESS
- total consumption of propofol [ Time Frame: end of operation assessment ]The investigators will measure the consumption of propofol intraoperatively
- total consumption of remifentanil [ Time Frame: end of operation assessment ]The investigators will measure the consumption of remifentanyl intraoperatively
- concentration of desflurane in end-expiratory gas [ Time Frame: intraoperative assessment ]The investigators will measure the concentration of desflurane in end-expiratory gas intraoperatively
- concentration of sevoflurane in end-expiratory gas [ Time Frame: intraoperative assessment ]The investigators will measure the concentration of sevoflurane in end-expiratory gas intraoperatively
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417180
| Contact: Michał J Stasiowski, MD | 696797922 ext 0048 | mstasiowski.anest@gmail.com | |
| Contact: Lech Krawczyk, Ph. Dr | 323682341 ext 0048 | lech.kraw@gmail.com |
| Poland | |
| Medical University of Silesia | Recruiting |
| Sosnowiec, Silesia, Poland, 41-200 | |
| Contact: Michał J. Stasiowski 696797922 ext 0048 mstasiowski.anest@gmail.com | |
| Contact: Lech Krawczyk, Ph. Dr. 323682341 ext 0048 lech.kraw@gmail.com | |
| Medical University of Silesia | Recruiting |
| Sosnowiec, Silesia, Poland, 41-200 | |
| Contact: Michał J Stasiowski, M.D 696797922 ext 0048 mstasiowski.anest@gmail.com | |
| Contact: Lech Krawczyk, Ph. Dr. 323682341 ext 0048 lech.kraw@gmail.com | |
| Principal Investigator: | Przemysław O Jałowiecki, Ph. Dr | Medical University of Silesia |
Other Publications:
| Responsible Party: | Michał Stasiowski, Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy, Medical University of Silesia |
| ClinicalTrials.gov Identifier: | NCT03417180 |
| Other Study ID Numbers: |
SilesianMUKOAiIT10 |
| First Posted: | January 31, 2018 Key Record Dates |
| Last Update Posted: | January 25, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | article in Laryngoscope in 2022, case reports |
| Supporting Materials: |
Informed Consent Form (ICF) |
| Time Frame: | starting 6 months after publication |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Surgical Pleth Index (SPI) Intraoperative Blood Loss (IBL) Boezaart Bleeding Scale (BBS) Spectral Entropy (SE) |
Adequacy of Anaesthesia (AoA) Total Intravenous Anaesthesia (TIVA) Sevoflurane Desflurane |
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Hemorrhage Pathologic Processes Remifentanil Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |