There is accumulating evidence that inappropriate analgesia is asssociated with increasing risk of perioperative complications. The aim of the study is to compare intraoperative analgesia guided according to different methods of intraoperative analgesia monitoring, ANI and SPI respectively.
The Surgical Pleth Index (SPI) and ANI (Analgesia Nociception Index) has been developed for monitoring of adequacy of analgesia during surgery. The investigators want to compare anesthesiologist guided intraoperative analgesia with intraoperative analgesia guieded by ANI or SPI. The following hypotheses have been made: 1. Anesthesiologist guided analgesia will result in lower surgical stress 2. Anesthesiologist guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
Sufentanil is given based on SPI value in the SPI guided analgesia group. The targer SPI range is set indiviudally based on the initial value of SPI recorded 5 minutes after the induction of anesthesia plus 10 points. In the ANI group, Sufentanil is given based on the ANI value, the target ANI range is 50 - 70. Values lower than 49 for 1 minute indicate the need of administering further dose of opioid, sufentanil is given in the same dose as initially. In the anesthesiologist guided analgesia group, Sufentanil is administered in a standardized manner.
Sufentanil is given based on ANI analgesia monitor figures in the sufentanil ANI analgesia group. Targeted ANI range is 50 - 70. Figures lower than 49 for 1 minute indicate the need of administering further dose of opioid, sufentanil is given in the same dose as initially and flushed with 20 ml of saline. The next dose of opioid can be given in the earliest after 3 minutes interval, if indicated according to ANI monitoring. The doses are repeated up to achievement of the targeted range of analgesia (ANI). The last dose of opioid can be given no later than 15 minutes before the end of surgery.
University Hospital Hradec Kralove
Hradec Králové, Czechia
Cortisol serum level
nmol/l
Time frame: End of surgery
Time to spontaneous ventilation
min
Time frame: From the end of anesthesia up to two hours
Time to extubation
min
Time frame: From the end of anesthesia up to two hours
Pain intensity at the time of departure from the operating theater
Assessment of pain using verbal pain scale (range 0-4)
Time frame: At the time of departure from the operating room, up to 30 min from the end of anesthesia
Pain intensity at recovery room admission
Assessment of pain using verbal pain scale (range 0-4)
Time frame: At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission
Mean pain intensity at the ICU/recovery room
Mean value of pain intensity score using verbal pain scale (range 0-4)
Time frame: From the admission to the ICU or recovery room up to 2 hours postoperatively
Postoperative respiratory complications
Number of participants with postoperative respiratory complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Sufentanil dose
microgramms per hour
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Sufentanil is given based on the anesthesiologist decision in the sufentanil anesthesiologist analgesia group. Sufentanil is administered in 20 minute intervals in a standardized manner, the same dose as initially is given and flushed with 20 ml of saline. Indication for additional administration of opioid beyond this interval is 25 % increase of systemic arterial pressure over the baseline and/or 35% increase of heart rate over the baseline. The next dose of opioid can be given in the earliest after 3 minutes interval. The doses are repeated up to achievement of the haemodynamic stability. The last dose of opioid can be given no later than 15 minutes before the end of surgery.
Time frame: From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours
Pain intensity
Assessment of pain using verbal pain scale (range 0-4)
Time frame: 1st postoperative day
Pain intensity
Assessment of pain using verbal pain scale (range 0-4)
Time frame: 2nd postoperative day
Pain intensity
Assessment of pain using verbal pain scale (range 0-4)
Time frame: 3rd postoperative day
Number of doses of opioid analgesics
The total number of doses of opioid analgesics during the 3 postoperative days
Time frame: Until the end of the 3rd postoperative day
Number of doses of non-opioid analgesics
The total number of doses of non-opioid analgesics during the 3 postoperative days
Time frame: Until the end of the 3rd postoperative day
Time to achievement of normal end-tidal CO2 value
min
Time frame: From the end of anesthesia up to two hours
Length of postoperative hospital stay
days
Time frame: From the day of surgery up to the end of hospital stay, an expected average of 2 weeks