ANI and SPI Guided Intraoperative Analgesia

NACompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

October 31, 2015

Study Completion Date

November 30, 2015

Conditions
Anesthesia
Interventions
DRUG

Sufentanil SPI analgesia

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.

DRUG

Sufentanil ANI analgesia

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.

DRUG

Sufentanil anesthesiologist analgesia

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.

Trial Locations (1)

50005

University Hospital Hradec Kralove, Hradec Králové

All Listed Sponsors
lead

University Hospital Hradec Kralove

OTHER

NCT02490540 - ANI and SPI Guided Intraoperative Analgesia | Biotech Hunter | Biotech Hunter