PRD-guided Analgesia During FESS for Intraoperative Blood Loss
- Conditions
- Endoscopic Sinus Surgery
- Interventions
- Device: pupillary dilatation reflex
- Registration Number
- NCT03417206
- Lead Sponsor
- Medical University of Silesia
- Brief Summary
The aim of this randomized trial is to assess the utility of Pupillary Dilatation Reflex (PRD) 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, Pupillary Dilatation Reflex (PRD) 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. PRD value \>5% reflects increased sensitivity to painful stimulus it constitutes the indication for administration of rescue analgesia intraoperatively.
This study aims at evaluating utility of PRD-directed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
-
- 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
- age under 18 years old
- allergy to propofol
- pregnancy
- any anatomical malformation making PRD or SE measurement impossible
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEVOFLURANE INHALATIONAL ANAESTHESIA pupillary dilatation reflex concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE between 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD\>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5% DESFLURANE INHALATIONAL ANAESTHESIA pupillary dilatation reflex concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD\>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5% TIVA USING PROPOROL pupillary dilatation reflex Infusion of propofol will be adjusted at target of SE 40,remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD\>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5% SEVOFLURANE INHALATIONAL ANAESTHESIA Remifentanil concentration of sevoflurane in the exhalation gas will be maintained to ensure target SE between 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD\>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5% DESFLURANE INHALATIONAL ANAESTHESIA Remifentanil concentration of desflurane in the exhalation gas will be maintained to ensure target SE 40, remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD\>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5% TIVA USING PROPOROL Remifentanil Infusion of propofol will be adjusted at target of SE 40,remifentanyl solution will be administered intravenously at a rate 0,25 mcg/kg of body weight/minute, intraoperatively PRD measurement every 15 minutes; when PRD\>5% infusion speed of remifentanyl will be increased by 50% every 5 minutes until PRD decreases below 5%
- 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 heart rate stability intraoperatively intraoperative assessment the investigators will measure heart rate during TIVAevery 5 minutes up to the end of the operation
PRD-guided pain perception intraoperatively 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
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
total consumption of remifentanil end of operation assessment The investigators will measure the consumption of remifentanyl intraoperatively
concentration of desflurane in end-expiratory gas intraoperative assessment The investigators will measure theconcentration 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