- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490540
ANI and SPI Guided Intraoperative Analgesia
September 28, 2019 updated by: Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
ANI and SPI Guided Intraoperative Analgesia in Patients Undergoing Neurosurgical Procedures Under General Anaesthesia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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:
- 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
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hradec Kralove, Czechia, 50005
- University hospital Hradec Králové
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anesthesiologist quided analgesia
Sufentanil anesthesiologist analgesia is based on anesthesiologist decision.
|
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:
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Experimental: ANI guided analgesia
Sufentanil ANI analgesia based on ANI analgesia monitor figures.
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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:
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Experimental: SPI guided analgesia
Sufentanil SPI analgesia is based on the SPI analgesia monitor figures.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol serum level
Time Frame: End of surgery
|
nmol/l
|
End of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to spontaneous ventilation
Time Frame: From the end of anesthesia up to two hours
|
min
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From the end of anesthesia up to two hours
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Time to extubation
Time Frame: From the end of anesthesia up to two hours
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min
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From the end of anesthesia up to two hours
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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
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Assessment of pain using verbal pain scale (range 0-4)
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At the time of departure from the operating room, up to 30 min from the end of anesthesia
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Pain intensity at recovery room admission
Time Frame: At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission
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Assessment of pain using verbal pain scale (range 0-4)
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At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission
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Mean pain intensity at the ICU/recovery room
Time Frame: From the admission to the ICU or recovery room up to 2 hours postoperatively
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Mean value of pain intensity score using verbal pain scale (range 0-4)
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From the admission to the ICU or recovery room up to 2 hours postoperatively
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Postoperative respiratory complications
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Number of participants with postoperative respiratory complications
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Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Sufentanil dose
Time Frame: From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours
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microgramms per hour
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From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours
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Pain intensity
Time Frame: 1st postoperative day
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Assessment of pain using verbal pain scale (range 0-4)
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1st postoperative day
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Pain intensity
Time Frame: 2nd postoperative day
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Assessment of pain using verbal pain scale (range 0-4)
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2nd postoperative day
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Pain intensity
Time Frame: 3rd postoperative day
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Assessment of pain using verbal pain scale (range 0-4)
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3rd postoperative day
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Number of doses of opioid analgesics
Time Frame: Until the end of the 3rd postoperative day
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The total number of doses of opioid analgesics during the 3 postoperative days
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Until the end of the 3rd postoperative day
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Number of doses of non-opioid analgesics
Time Frame: Until the end of the 3rd postoperative day
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The total number of doses of non-opioid analgesics during the 3 postoperative days
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Until the end of the 3rd postoperative day
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Time to achievement of normal end-tidal CO2 value
Time Frame: From the end of anesthesia up to two hours
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min
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From the end of anesthesia up to two hours
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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
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From the day of surgery up to the end of hospital stay, an expected average of 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
June 18, 2015
First Submitted That Met QC Criteria
July 1, 2015
First Posted (Estimate)
July 7, 2015
Study Record Updates
Last Update Posted (Actual)
October 1, 2019
Last Update Submitted That Met QC Criteria
September 28, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201506S 38P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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