ANI and SPI Guided Intraoperative Analgesia

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Sufentanil SPI analgesia
* Drug: Sufentanil ANI analgesia
* Drug: Sufentanil anesthesiologist analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anesthesiologist quided analgesia<br>Sufentanil anesthesiologist analgesia is based on anesthesiologist decision. | Drug: Sufentanil anesthesiologist analgesia<br>* 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.<br>* Other names: Sufentanil, anesthesiologist;|
| Experimental: ANI guided analgesia<br>Sufentanil ANI analgesia based on ANI analgesia monitor figures. | Drug: Sufentanil ANI analgesia<br>* 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.<br>* Other names: Sufentanil, ANI;|
| Experimental: SPI guided analgesia<br>Sufentanil SPI analgesia is based on the SPI analgesia monitor figures. | Drug: Sufentanil SPI analgesia<br>* 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.<br>* Other names: Sufentanil, SPI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol serum level | nmol/l | End of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to spontaneous ventilation | min | From the end of anesthesia up to two hours | 
| Time to extubation | min | From the end of anesthesia up to two hours | 
| Pain intensity at the time of departure from the operating theater | Assessment of pain using verbal pain scale (range 0-4) | At the time of departure from the operating room, up to 30 min from the end of anesthesia | 
| Pain intensity at recovery room admission | Assessment of pain using verbal pain scale (range 0-4) | At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission | 
| Mean pain intensity at the ICU/recovery room | Mean value of pain intensity score using verbal pain scale (range 0-4) | From the admission to the ICU or recovery room up to 2 hours postoperatively | 
| Postoperative respiratory complications | Number of participants with postoperative respiratory complications | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Sufentanil dose | microgramms per hour | From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours | 
| Pain intensity | Assessment of pain using verbal pain scale (range 0-4) | 1st postoperative day | 
| Pain intensity | Assessment of pain using verbal pain scale (range 0-4) | 2nd postoperative day | 
| Pain intensity | Assessment of pain using verbal pain scale (range 0-4) | 3rd postoperative day | 
| Number of doses of opioid analgesics | The total number of doses of opioid analgesics during the 3 postoperative days | Until the end of the 3rd postoperative day | 
| Number of doses of non-opioid analgesics | The total number of doses of non-opioid analgesics during the 3 postoperative days | Until the end of the 3rd postoperative day | 
| Time to achievement of normal end-tidal CO2 value | min | From the end of anesthesia up to two hours | 
| Length of postoperative hospital stay | days | From the day of surgery up to the end of hospital stay, an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioids, analgesia, pain, anesthesia