AnesthesiaNCT02490540
ANI and SPI Guided Intraoperative Analgesia
A study testing Sufentanil SPI analgesia, Sufentanil ANI analgesia and Sufentanil anesthesiologist analgesia in people with Anesthesia, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sufentanil SPI analgesia, Sufentanil ANI analgesia and Sufentanil anesthesiologist analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing scheduled neurosurgical procedures under general anesthesia
- GCS 15
- ASA physical status I - III
- elective procedures with estimated duration 1 - 3 hours
Who cannot join
- Presence of non-sinus rhythm
- pacemaker
- planned postoperative ventilation
- procedures with planned awake intervals
- chronic pain with opioid medication
- opioid addiction
Show all 10Show fewer
- epidural administration of local anaesthetic in combination with opioid
- corticosteroid use
- hormonal contraception
- chronic respiratory disease with known respiratory failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Anesthesia
- Being tested
- Sufentanil SPI analgesia, Sufentanil ANI analgesia, Sufentanil anesthesiologist analgesia
- Keywords
- opioids, analgesia, pain, anesthesia
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil SPI analgesiaDrug
Also called Sufentanil, SPI
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.
Sufentanil ANI analgesiaDrug
Also called Sufentanil, ANI
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.
Sufentanil anesthesiologist analgesiaDrug
Also called Sufentanil, anesthesiologist
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.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesiologist quided analgesia | Experimental | Sufentanil anesthesiologist analgesia is based on anesthesiologist decision. Receives: Drug: Sufentanil anesthesiologist analgesia |
| ANI guided analgesia | Experimental | Sufentanil ANI analgesia based on ANI analgesia monitor figures. Receives: Drug: Sufentanil ANI analgesia |
| SPI guided analgesia | Experimental | Sufentanil SPI analgesia is based on the SPI analgesia monitor figures. Receives: Drug: Sufentanil SPI analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol serum level
nmol/l
Measured: End of surgery
Secondary outcomes (14)
Time to spontaneous ventilation
min
Measured: From the end of anesthesia up to two hours
Time to extubation
min
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From the admission to the ICU or recovery room up to 2 hours postoperatively
Postoperative respiratory complications
Number of participants with postoperative respiratory complications
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Sufentanil dose
microgramms per hour
Measured: 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)
Measured: 1st postoperative day
Pain intensity
Assessment of pain using verbal pain scale (range 0-4)
Measured: 2nd postoperative day
Pain intensity
Assessment of pain using verbal pain scale (range 0-4)
Measured: 3rd postoperative day
Number of doses of opioid analgesics
The total number of doses of opioid analgesics during the 3 postoperative days
Measured: 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
Measured: Until the end of the 3rd postoperative day
Time to achievement of normal end-tidal CO2 value
min
Measured: From the end of anesthesia up to two hours
Length of postoperative hospital stay
days
Measured: From the day of surgery up to the end of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Vlasta Dostalova, MD, PhD, Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490540
- Sponsor's protocol ID
- 201506S 38P
- Status last verified
- Sep 2019
- First submitted
- 18 Jun 2015
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANI and SPI Guided Intraoperative Analgesia in Patients Undergoing Neurosurgical Procedures Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT02490540
- Acronym / sponsor ID
- 201506S 38P
- Conditions
- Anesthesia
- Keywords
- opioids, analgesia, pain, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anesthesiologist quided analgesia | Experimental | Drug: Sufentanil anesthesiologist analgesiaSufentanil anesthesiologist analgesia is based on anesthesiologist decision. |
| ANI guided analgesia | Experimental | Drug: Sufentanil ANI analgesiaSufentanil ANI analgesia based on ANI analgesia monitor figures. |
| SPI guided analgesia | Experimental | Drug: Sufentanil SPI analgesiaSufentanil SPI analgesia is based on the SPI analgesia monitor figures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing scheduled neurosurgical procedures under general anesthesia
- GCS 15
- ASA physical status I - III
- elective procedures with estimated duration 1 - 3 hours
Key exclusion criteria (10 listed)
- Presence of non-sinus rhythm
- pacemaker
- planned postoperative ventilation
- procedures with planned awake intervals
- chronic pain with opioid medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil SPI analgesiaAlso: Sufentanil, SPISufentanil 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. | Drug | SPI guided analgesia |
| Sufentanil ANI analgesiaAlso: Sufentanil, ANISufentanil 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. | Drug | ANI guided analgesia |
| Sufentanil anesthesiologist analgesiaAlso: Sufentanil, anesthesiologistSufentanil 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. | Drug | Anesthesiologist quided analgesia |
Primary outcome
Cortisol serum level
Time frame: End of surgery
nmol/l
14 secondary outcomes
Time to spontaneous ventilation
Time frame: From the end of anesthesia up to two hours
Time to extubation
Time frame: From the end of anesthesia up to two hours
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
Pain intensity at recovery room admission
Time frame: At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission
Mean pain intensity at the ICU/recovery room
Time frame: From the admission to the ICU or recovery room up to 2 hours postoperatively
Postoperative respiratory complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Sufentanil dose
Time frame: From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours
Pain intensity
Time frame: 1st postoperative day
Pain intensity
Time frame: 2nd postoperative day
Pain intensity
Time frame: 3rd postoperative day
Number of doses of opioid analgesics
Time frame: Until the end of the 3rd postoperative day
Number of doses of non-opioid analgesics
Time frame: Until the end of the 3rd postoperative day
Time to achievement of normal end-tidal CO2 value
Time frame: From the end of anesthesia up to two hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vlasta Dostalova, MD, PhD principal investigator
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil SPI analgesia, Sufentanil ANI analgesia and Sufentanil anesthesiologist analgesia in people with Anesthesia, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol serum level (time frame: End of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.