ANI and SPI Guided Intraoperative Analgesia
- Conditions
- Anesthesia
- Interventions
- Registration Number
- NCT02490540
- Lead Sponsor
- University Hospital Hradec Kralove
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Patients undergoing scheduled neurosurgical procedures under general anesthesia
- GCS 15
- ASA physical status I - III
- elective procedures with estimated duration 1 - 3 hours
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anesthesiologist quided analgesia Sufentanil anesthesiologist analgesia Sufentanil anesthesiologist analgesia is based on anesthesiologist decision. SPI guided analgesia Sufentanil SPI analgesia Sufentanil SPI analgesia is based on the SPI analgesia monitor figures. ANI guided analgesia Sufentanil ANI analgesia Sufentanil ANI analgesia based on ANI analgesia monitor figures.
- Primary Outcome Measures
Name Time Method Cortisol serum level End of surgery nmol/l
- Secondary Outcome Measures
Name Time Method Time to spontaneous ventilation From the end of anesthesia up to two hours min
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)
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
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
Sufentanil dose From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours microgramms per hour
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)
Time to achievement of normal end-tidal CO2 value From the end of anesthesia up to two hours min
Pain intensity 3rd postoperative day Assessment of pain using verbal pain scale (range 0-4)
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
Length of postoperative hospital stay From the day of surgery up to the end of hospital stay, an expected average of 2 weeks days
Time to extubation From the end of anesthesia up to two hours min
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)
Trial Locations
- Locations (1)
University Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia