Balanced AnesthesiaNCT01525537
Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia
A study testing administration of sufentanil and sufentanil in people with Balanced Anesthesia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The aim of the present study was to compare SPI guided analgesia with standard clinical practise during general anesthesia using a balanced setting of sevoflurane and sufentanil anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Balanced Anesthesia
- What is being tested?
- administration of sufentanil and sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Oct 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 - 65 years
- ASA physical status I or II
- elective surgery under general anesthesia of 1-2 hours
- written informed consent
Who cannot join
- pregnancy
- history of cardiac arrhythmia
- presence of any neuromuscular opr neurologic disease
- use of CNS active medication or alcohol/illicit drug abuse -
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.
Kiel, 24105
About this study
Official title: Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia
The aim of the present study was to compare SPI guided analgesia with standard clinical practise during general anesthesia using a balanced setting of sevoflurane and sufentanil anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular stability, less use of analgetics and shorter recovery from anesthesia.
Read the detailed description
General anesthesia can be considered as a combination of hypnosis, antinociception, and immobility. The monitoring of hypnosis and immobility has been established in clinical practise, however for the evaluation of antinociception a valid monitoring is missing.
The Surgical Pleth Index (SPI; former named Surgical Stress Index-SSI) is a multivariate index derived non invasively from finger plethysmographic signal. It has been demonstrated to correlate with surgical stress intensity. In the setting of total intravenous anesthesia TIVA our group could show beneficial effects of SPI guided analgesia in terms of remifentanil consumption, hemodynamic stability and incidence of unwanted events.
Therefore, we wanted examine whether these beneficial effects of SPI guided anesthesia can be transferred to a setting of balanced anesthesia using a volatile anesthetic sevoflurane and the opioid sufentanil.
The following hypotheses have been made:
- SPI guided analgesia will result in less sufentanil consumption
- SPI guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia, and less opioid use in post operative period
- Conditions
- Balanced Anesthesia
- Being tested
- administration of sufentanil, sufentanil
- Keywords
- Anesthesia General, Anesthetics Inhalation, Diagnostic techniques and procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of sufentanilDrug
10 microgram sufentanil were given when SPI above 50 for more then 20 sec
sufentanilDrug
sufentanil was given at standard practise
| Study group | Role | What they receive |
|---|---|---|
| SPI guided arm | Experimental | sufentanil was adjusted to SPI level Receives: Drug: administration of sufentanil |
| Standard practise | Active comparator | Sufentanil was given at standard practise Receives: Drug: sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sufentanil consumption
We will measure the sufentanil consumption during beginning of anesthesia and extubation in microgram per hour.
Measured: during induction and end of anesthesia (1-3 hours)
Secondary outcomes (1)
hemodynamic stability
Hemodynamic stability is measured as number of the following events during anesthesia: hypotension, hypertension, tachykardia, bradykardia.
Measured: from beginning of anesthesia until discharge to ward (1day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Balanced 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Bein, University Hospital Schleswig-Holstein
- Investigators
- Berthold Bein, MD, PhD, Study chair, University Hospital Schleswig-HolsteinMatthias Gruenewald, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525537
- Sponsor's protocol ID
- SPI-134-2
- Status last verified
- Jun 2012
- First submitted
- 26 Jan 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen X, Thee C, Gruenewald M, Wnent J, Illies C, Hoecker J, Hanss R, Steinfath M, Bein B. Comparison of surgical stress index-guided analgesia with standard clinical practice during routine general anesthesia: a pilot study. Anesthesiology. 2010 May;112(5):1175-83. doi: 10.1097/ALN.0b013e3181d3d641.
PubMed 20418698Gruenewald M, Meybohm P, Ilies C, Hocker J, Hanss R, Scholz J, Bein B. Influence of different remifentanil concentrations on the performance of the surgical stress index to detect a standardized painful stimulus during sevoflurane anaesthesia. Br J Anaesth. 2009 Oct;103(4):586-93. doi: 10.1093/bja/aep206. Epub 2009 Jul 31.
PubMed 19648155Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
PubMed 24535604
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia
- ClinicalTrials.gov ID
- NCT01525537
- Acronym / sponsor ID
- SPI-134-2
- Conditions
- Balanced Anesthesia
- Keywords
- Anesthesia General, Anesthetics Inhalation, Diagnostic techniques and procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Feb 2012 (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.
The aim of the present study was to compare SPI guided analgesia with standard clinical practise during general anesthesia using a balanced setting of sevoflurane and sufentanil anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular stability, less use of analgetics and shorter recovery from anesthesia.
Detailed description
General anesthesia can be considered as a combination of hypnosis, antinociception, and immobility. The monitoring of hypnosis and immobility has been established in clinical practise, however for the evaluation of antinociception a valid monitoring is missing.
The Surgical Pleth Index (SPI; former named Surgical Stress Index-SSI) is a multivariate index derived non invasively from finger plethysmographic signal. It has been demonstrated to correlate with surgical stress intensity. In the setting of total intravenous anesthesia TIVA our group could show beneficial effects of SPI guided analgesia in terms of remifentanil consumption, hemodynamic stability and incidence of unwanted events.
Therefore, we wanted examine whether these beneficial effects of SPI guided anesthesia can be transferred to a setting of balanced anesthesia using a volatile anesthetic sevoflurane and the opioid sufentanil.
The following hypotheses have been made:
- SPI guided analgesia will result in less sufentanil consumption
- SPI guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia, and less opioid use in post operative period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI guided arm | Experimental | Drug: administration of sufentanilsufentanil was adjusted to SPI level |
| Standard practise | Active comparator | Drug: sufentanilSufentanil was given at standard practise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 - 65 years
- ASA physical status I or II
- elective surgery under general anesthesia of 1-2 hours
- written informed consent
Key exclusion criteria (4 listed)
- pregnancy
- history of cardiac arrhythmia
- presence of any neuromuscular opr neurologic disease
- use of CNS active medication or alcohol/illicit drug abuse -
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 |
|---|---|---|
| administration of sufentanil10 microgram sufentanil were given when SPI above 50 for more then 20 sec | Drug | SPI guided arm |
| sufentanilsufentanil was given at standard practise | Drug | Standard practise |
Primary outcome
Sufentanil consumption
Time frame: during induction and end of anesthesia (1-3 hours)
We will measure the sufentanil consumption during beginning of anesthesia and extubation in microgram per hour.
1 secondary outcome
hemodynamic stability
Time frame: from beginning of anesthesia until discharge to ward (1day)
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 15 Jun 2012.
- Background: PubMed 20418698Chen X, Thee C, Gruenewald M, Wnent J, Illies C, Hoecker J, Hanss R, Steinfath M, Bein B. Comparison of surgical stress index-guided analgesia with standard clinical practice during routine general anesthesia: a pilot study. Anesthesiology. 2010 May;112(5):1175-83. doi: 10.1097/ALN.0b013e3181d3d641.
- Background: PubMed 19648155Gruenewald M, Meybohm P, Ilies C, Hocker J, Hanss R, Scholz J, Bein B. Influence of different remifentanil concentrations on the performance of the surgical stress index to detect a standardized painful stimulus during sevoflurane anaesthesia. Br J Anaesth. 2009 Oct;103(4):586-93. doi: 10.1093/bja/aep206. Epub 2009 Jul 31.
- Derived from this study: PubMed 24535604Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
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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.
Berthold Bein, MD, PhD study chair
University Hospital Schleswig-Holstein
Matthias Gruenewald, MD principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of sufentanil and sufentanil in people with Balanced Anesthesia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 4 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 15 Jun 2012. 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 Germany. 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?
Sufentanil consumption (time frame: during induction and end of anesthesia (1-3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01525537, which also lists 3 linked publications.
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 15 Jun 2012.