Intraoperative ComplicationsNCT04519203
The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery
A study testing SPI and Standard in people with Intraoperative Complications and Intraoperative Hypotension, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Surgical Pleth Index (SPI) is an intraoperative monitor aimed into detection of nociception and guidance of intraoperative opioid administration. Using such a device opioid administration could be potentially optimized during intraoperative period. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Complications, Intraoperative Hypotension, Intraoperative Hypertension
- What is being tested?
- SPI and Standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 9 Sep 2020to 1 Nov 2021
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide a written informed consent
- Age 50 years or above
- Laparoscopic or laparotomic surgery requiring intubation with an expected intraoperative time at least two hours.
- ASA classification 1-3
Who cannot join
- Implanted cardiac pacemaker or known condition with irregular heart rate at the time of inclusion or induction
- Chronic use of opioids
- BMI >35
- Known allergy for study medications
- Over 5 extrasystoles per minute at the time of induction or inclusion
- The use of epidural catheter during the last one hour before surgery or need for catheter intraoperatively (if new catheter is placed at the beginning of surgery test dosage may be used without the need for patient exclusion)
Trial locations and contacts
1 site in 1 country.
About this study
Surgical Pleth Index (SPI) is an intraoperative monitor aimed into detection of nociception and guidance of intraoperative opioid administration. Using such a device opioid administration could be potentially optimized during intraoperative period. this study will aim to show whether SPI could be used to reduce unwanted events and lower opioid consumption in gastroenterological surgery. The study will be blinded and randomized including two study arms with either SPI monitoring included or standard monitoring alone.
Read the detailed description
Patients are extensively monitored intraoperatively. Even though there are monitors for the measurement of nociception, it has not gained wide acceptance partly because of limited and scarce evidence on the efficacy and optimal use. Especially elderly patients undergoing major operation might benefit from optimization of opioid administration. Surgical Pleth Index (SPI) is an intraoperative monitoring aimed for detection of nociceptive stimulus.
The aim of this research is to study whether SPI could be used to guide opioid administration in gastroenterological surgery. The study will consist of a total 80 patients which are randomized into two groups. The study sample is based on power calculation for the reduction of remifentanil consumption.
In the study group the opioid administration will be guided using a SPI based protocol. In the control group the opioid administration will be based on standard monitoring and clinical decision alone. The aim of the study will be to study whether opioid administration optimized using SPI can lover need for anticholinergic drugs, reduce need for opioids or diminish the amount of unwanted side effects postoperatively. The patients will be treated using target controlled infusions of remifentanil and propofol.
The data will be collected intraoperatively using electronic software and using a study data collection form by study personel. All study procedures will take place during operative period.
The study power was calculated using a study comparing depth of anesthesia and depth of nociception balance-controlled group into a group without these monitors. In the group with monitoring the consumption of remifentanil was 9,5±3.8 mg/kg/h while in the unmonitored group the consumption was 12.3 mg/kg/h(Chen, 2010). While taking into notice α= 0,005 and β=90% a number of 39 patients in each group is needed. Based on these we chose 80 patients to be included in the study.
All collected data will be used into statistical analysis ass applicable. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
- Being tested
- SPI, Standard
- Keywords
- Nociception, Intraoperative monitoring, Surgical pleth index
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIDevice
Either standard monitoring alone or added with SPI
StandardDevice
Standard monitoring alone
| Study group | Role | What they receive |
|---|---|---|
| SPI group | Active comparator | Group of patients where opioid consumption will be guided using SPI target Receives: Device: SPI |
| Control Group | Active comparator | Group of patients where only standard monitoring and patient reaction will be used to guide opioid administration during intraoperative period Receives: Device: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption
The consumption of the remifentanil intraoperatively
Measured: intraoperative time
Secondary outcomes (10)
severe hypotension
MAP <55 mmHg, or -30% from the baseline value
Measured: intraoperative time
intermediate hypotension
MAP <65 mmHg, or -20% from the baseline value
Measured: intraoperative time
hypertension
RRsys >140 mmHg or +20 % from baseline value
Measured: intraoperative time
Bradycardia
Heart rate<45
Measured: intraoperative time
tachycardia
Heart rate>90
Measured: intraoperative time
Inraoperative propofol consumption
Measured: intraoperative time
Desorientation/ grade of sedation during postoperative care treatment
The postoperative desoroentation during immediate post-operative period at postanesthesia care unit. Measured using modified aldrete score
Measured: 2-4 hours
Postoperative nausea and vomiting
The postoperative nausea and vomiting during immediate post-operative period at postanesthesia care unit. Measured using modified aldrete score.
Measured: 2-4 hours
Postoperative opioid consumption
The postoperative opioid consumption during immediate post-operative period at postanesthesia care unit.
Measured: 2-4 hours
Fading of intraoperative relaxation
The characteristics of intraoperative relaxation using EMG measurement
Measured: intraoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start9 Sep 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- general electric healthcare Finland
- Responsible party
- Sponsor
- Investigators
- Jarkko Harju, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519203
- Sponsor's protocol ID
- R20006
- Status last verified
- Apr 2021
- First submitted
- 21 Feb 2020
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery
- ClinicalTrials.gov ID
- NCT04519203
- Acronym / sponsor ID
- R20006
- Keywords
- Nociception, Intraoperative monitoring, Surgical pleth index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- general electric healthcare Finland
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 19 Aug 2020 (actual)
- 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.
Surgical Pleth Index (SPI) is an intraoperative monitor aimed into detection of nociception and guidance of intraoperative opioid administration. Using such a device opioid administration could be potentially optimized during intraoperative period. this study will aim to show whether SPI could be used to reduce unwanted events and lower opioid consumption in gastroenterological surgery. The study will be blinded and randomized including two study arms with either SPI monitoring included or standard monitoring alone.
Detailed description
Patients are extensively monitored intraoperatively. Even though there are monitors for the measurement of nociception, it has not gained wide acceptance partly because of limited and scarce evidence on the efficacy and optimal use. Especially elderly patients undergoing major operation might benefit from optimization of opioid administration. Surgical Pleth Index (SPI) is an intraoperative monitoring aimed for detection of nociceptive stimulus.
The aim of this research is to study whether SPI could be used to guide opioid administration in gastroenterological surgery. The study will consist of a total 80 patients which are randomized into two groups. The study sample is based on power calculation for the reduction of remifentanil consumption.
In the study group the opioid administration will be guided using a SPI based protocol. In the control group the opioid administration will be based on standard monitoring and clinical decision alone. The aim of the study will be to study whether opioid administration optimized using SPI can lover need for anticholinergic drugs, reduce need for opioids or diminish the amount of unwanted side effects postoperatively. The patients will be treated using target controlled infusions of remifentanil and propofol.
The data will be collected intraoperatively using electronic software and using a study data collection form by study personel. All study procedures will take place during operative period.
The study power was calculated using a study comparing depth of anesthesia and depth of nociception balance-controlled group into a group without these monitors. In the group with monitoring the consumption of remifentanil was 9,5±3.8 mg/kg/h while in the unmonitored group the consumption was 12.3 mg/kg/h(Chen, 2010). While taking into notice α= 0,005 and β=90% a number of 39 patients in each group is needed. Based on these we chose 80 patients to be included in the study.
All collected data will be used into statistical analysis ass applicable. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI group | Active comparator | Device: SPIGroup of patients where opioid consumption will be guided using SPI target |
| Control Group | Active comparator | Device: StandardGroup of patients where only standard monitoring and patient reaction will be used to guide opioid administration during intraoperative period |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide a written informed consent
- Age 50 years or above
- Laparoscopic or laparotomic surgery requiring intubation with an expected intraoperative time at least two hours.
- ASA classification 1-3
Key exclusion criteria (6 listed)
- Implanted cardiac pacemaker or known condition with irregular heart rate at the time of inclusion or induction
- Chronic use of opioids
- BMI >35
- Known allergy for study medications
- Over 5 extrasystoles per minute at the time of induction or inclusion
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 |
|---|---|---|
| SPIEither standard monitoring alone or added with SPI | Device | SPI group |
| StandardStandard monitoring alone | Device | Control Group |
Primary outcome
Intraoperative remifentanil consumption
Time frame: intraoperative time
The consumption of the remifentanil intraoperatively
10 secondary outcomes
severe hypotension
Time frame: intraoperative time
intermediate hypotension
Time frame: intraoperative time
hypertension
Time frame: intraoperative time
Bradycardia
Time frame: intraoperative time
tachycardia
Time frame: intraoperative time
Inraoperative propofol consumption
Time frame: intraoperative time
Desorientation/ grade of sedation during postoperative care treatment
Time frame: 2-4 hours
Postoperative nausea and vomiting
Time frame: 2-4 hours
Postoperative opioid consumption
Time frame: 2-4 hours
Fading of intraoperative relaxation
Time frame: intraoperative time
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 25 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Jarkko Harju, MD, PhD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPI and Standard in people with Intraoperative Complications and Intraoperative Hypotension, run by Tampere University Hospital at 1 site in Finland.
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 6 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 25 Nov 2024. 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 Finland. 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?
Intraoperative remifentanil consumption (time frame: intraoperative time). 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 25 Nov 2024.