University Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
NCT Number: NCT02490540
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hradec Králové, 50005, Czechia
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Sufentanil, SPI
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.
Other names: Sufentanil, ANI
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.
Other names: Sufentanil, anesthesiologist
Time frame: End of surgery
nmol/l
Time frame: From the end of anesthesia up to two hours
min
Time frame: From the end of anesthesia up to two hours
min
Time frame: At the time of departure from the operating room, up to 30 min from the end of anesthesia
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
Assessment of pain using verbal pain scale (range 0-4)
Time frame: From the admission to the ICU or recovery room up to 2 hours postoperatively
Mean value of pain intensity score using verbal pain scale (range 0-4)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Number of participants with postoperative respiratory complications
Time frame: From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours
microgramms per hour
Time frame: 1st postoperative day
Assessment of pain using verbal pain scale (range 0-4)
Time frame: 2nd postoperative day
Assessment of pain using verbal pain scale (range 0-4)
Time frame: 3rd postoperative day
Assessment of pain using verbal pain scale (range 0-4)
Time frame: Until the end of the 3rd postoperative day
The total number of doses of opioid analgesics during the 3 postoperative days
Time frame: Until the end of the 3rd postoperative day
The total number of doses of non-opioid analgesics during the 3 postoperative days
Time frame: From the end of anesthesia up to two hours
min
Time frame: From the day of surgery up to the end of hospital stay, an expected average of 2 weeks
days
University Hospital Hradec Kralove
Other
ANI and SPI Guided Intraoperative Analgesia in Patients Undergoing Neurosurgical Procedures Under General Anaesthesia
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