Anesthesia
Conditions
Keywords
opioids, analgesia, pain, anesthesia
Brief 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
Interventions
DRUGSufentanil 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.
DRUGSufentanil 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.
DRUGSufentanil 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.
Sponsors
University Hospital Hradec Kralove
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol serum level | End of surgery | nmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at recovery room admission | 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) |
| Mean pain intensity at the ICU/recovery room | 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 to spontaneous ventilation | From the end of anesthesia up to two hours | min |
| Time to extubation | From the end of anesthesia up to two hours | min |
| Postoperative respiratory complications | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Number of participants with postoperative respiratory complications |
| Pain intensity at the time of departure from the operating theater | 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) |
| Pain intensity | 1st postoperative day | Assessment of pain using verbal pain scale (range 0-4) |
| Number of doses of opioid analgesics | Until the end of the 3rd postoperative day | The total number of doses of opioid analgesics during the 3 postoperative days |
| Number of doses of non-opioid analgesics | Until the end of the 3rd postoperative day | The total number of doses of non-opioid analgesics during the 3 postoperative days |
| Time to achievement of normal end-tidal CO2 value | From the end of anesthesia up to two hours | min |
| Length of postoperative hospital stay | From the day of surgery up to the end of hospital stay, an expected average of 2 weeks | days |
| Sufentanil dose | From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours | microgramms per hour |
Countries
Czechia
Outcome results
None listed