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Completed

NCT Number: NCT02490540

ANI and SPI Guided Intraoperative Analgesia

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

About this study

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:

  • Anesthesiologist guided analgesia will result in lower surgical stress
  • Anesthesiologist guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing scheduled neurosurgical procedures under general anesthesia
  • GCS 15
  • ASA physical status I - III
  • elective procedures with estimated duration 1 - 3 hours

Exclusion criteria

  • Presence of non-sinus rhythm
  • pacemaker
  • planned postoperative ventilation
  • procedures with planned awake intervals
  • chronic pain with opioid medication
  • opioid addiction
  • epidural administration of local anaesthetic in combination with opioid
  • corticosteroid use
  • hormonal contraception
  • chronic respiratory disease with known respiratory failure

Treatment and study plan

Sufentanil SPI analgesia

Drug

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 ANI analgesia

Drug

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 anesthesiologist analgesia

Drug

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

Primary outcomes

  1. Cortisol serum level

    Time frame: End of surgery

    nmol/l

Secondary outcomes

  1. Time to spontaneous ventilation

    Time frame: From the end of anesthesia up to two hours

    min

  2. Time to extubation

    Time frame: From the end of anesthesia up to two hours

    min

  3. Pain intensity at the time of departure from the operating theater

    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)

  4. Pain intensity at recovery room admission

    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)

  5. Mean pain intensity at the ICU/recovery room

    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)

  6. Postoperative respiratory complications

    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

  7. Sufentanil dose

    Time frame: From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours

    microgramms per hour

  8. Pain intensity

    Time frame: 1st postoperative day

    Assessment of pain using verbal pain scale (range 0-4)

  9. Pain intensity

    Time frame: 2nd postoperative day

    Assessment of pain using verbal pain scale (range 0-4)

  10. Pain intensity

    Time frame: 3rd postoperative day

    Assessment of pain using verbal pain scale (range 0-4)

  11. Number of doses of opioid analgesics

    Time frame: Until the end of the 3rd postoperative day

    The total number of doses of opioid analgesics during the 3 postoperative days

  12. Number of doses of non-opioid analgesics

    Time frame: Until the end of the 3rd postoperative day

    The total number of doses of non-opioid analgesics during the 3 postoperative days

  13. Time to achievement of normal end-tidal CO2 value

    Time frame: From the end of anesthesia up to two hours

    min

  14. Length of postoperative hospital stay

    Time frame: From the day of surgery up to the end of hospital stay, an expected average of 2 weeks

    days

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 7, 2015
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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