NCT02490540

ANI and SPI Guided Intraoperative Analgesia

ANI and SPI Guided Intraoperative Analgesia in Patients Undergoing Neurosurgical Procedures Under General Anaesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Anesthesia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-07-07
• Last updated: 2019-10-01

Locations

1 site across 1 country: Czechia