Loss of ConsciousnessNCT02831101
Sufentanil Bispectral Index Elderly
A study testing Sufentanil in people with Loss of Consciousness, run by University Hospital, Geneva.
Trial summary
We compared BIS values during propofol stepwise induction with or without concomitant sufentanil in patients ≥ 65 years . Read more about this study
- Who is it for?
- Ages 70 to 87 years
- Conditions the study is for
- Loss of Consciousness
- What is being tested?
- Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to 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 70 to 87 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years
Who cannot join
- History of heart disease
- History of renal disease
- History of psychiatric
- Obesity
- Allergy to propofol or sufentanil
About this study
Official title: Impact of Sufentanil on the Depth of Sedation Measured by Bispectral Index During Induction of Anaesthesia With Propofol in the Elderly - a Randomised Trial
We compared BIS values during propofol stepwise induction with or without concomitant sufentanil in patients ≥ 65 years .
Read the detailed description
Bispectral index (BIS) is widely used to estimate the depth of anesthesia. In clinical studies, a large variability of BIS has been observed. Several factors may be responsible for this inconsistency. We were able to show that in elderly patients (average age 78 years) receiving increasing doses of propofol alone a BIS values at loss of consciousness (LOC) were about 30% higher compared with young patients (average age 35 years). We showed also that in young patients (average age 48 years) the BIS values at LOC were significantly higher in those receiving sufentanil concomitantly with propofol compared with those who had received propofol alone. It remains unknown, however, whether these data from young surgical patients are applicable to a population of elderly patients. It may be argued that in the elderly receiving propofol, the impact of advance age was so important that any addition of an opioid would not further disturb the sedation-monitor balance. Alternatively, it may be expected that in the elderly receiving an opioid added to propofol the impact of both drugs on sedation will be additive and that previous observations from younger patients will be further exaggerated. The impact of advance age and presence or absence of sufentanil during propofol induction on BIS values at LOC was investigated in this trial.
- Conditions
- Loss of Consciousness
- Being tested
- Sufentanil, Placebo
- Keywords
- BIS, Elderly, Propofol, Sufentanil, Loss of consciousness
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
To evaluate, in the elderly, the impact of a concomitant administration of sufentanil during a step-wise propofol induction of anaesthesia on the depth of sedation measured using BIS and clinical sedation score.
PlaceboDrug
To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil | Experimental | Sufentanil intravenously, continuously with effect-site concentration of 0.3 ng/ml until the end of the study Receives: Drug: Sufentanil |
| Placebo | Other | Saline intravenously, continuously with the same effect-site concentration as sufentanil (recorded on administration device) until the end of the study Receives: Drug: Placebo |
| Propofol | No intervention | Open administration using a separate target controlled infusion system and the PK/PD model by Schnider. Initial effect-site concentration 0.5 mcg/ml increased by 0.5 mcg/ml until LOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS at baseline
BIS values in awake patient in supine position, eyes closed, quiet environment
Measured: BIS values at baseline before administration of any study drugs
BIS and sufentanil
BIS values recorded after the steady state concentration was obtained and kept during 10min.
Measured: BIS values 10 min after steady state concentration of sufentanil
BIS and propofol
Propofol was administrated step-wise by increasing concentration of 0.5mcg/ml (0.5, 1.0, 1.5 etc.). After each steady state that was kept during 5 min, BIS values were recorded
Measured: BIS values after steady state concentration of propofol
BIS and LOC
BIS values were recorded at LOC, that was estimated using a OAA/S scale, a 0-5 point scale, 5 corresponds to a fully awake state, a score of 0 to a completely unresponsive state. A score <2 (absence of response to mild prodding or shaking was regarded as LOC. Blinded to study drug investigator evaluated all sedation scores.
Measured: BIS values at loss of consciousness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startFeb 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Loss of ConsciousnessStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Lysakowski, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831101
- Sponsor's protocol ID
- CER 11-25, NAC 11-78
- Status last verified
- Oct 2017
- First submitted
- 1 Jul 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Valence T, Elia N, Czarnetzki C, Dumont L, Tramer MR, Lysakowski C. Effect of sufentanil on bispectral index in the elderly. Anaesthesia. 2018 Feb;73(2):216-222. doi: 10.1111/anae.14102. Epub 2017 Nov 3.
PubMed 29098683
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sufentanil on the Depth of Sedation Measured by Bispectral Index During Induction of Anaesthesia With Propofol in the Elderly - a Randomised Trial
- ClinicalTrials.gov ID
- NCT02831101
- Acronym / sponsor ID
- CER 11-25, NAC 11-78
- Conditions
- Loss of Consciousness
- Keywords
- BIS, Elderly, Propofol, Sufentanil, Loss of consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Jul 2016 (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.
We compared BIS values during propofol stepwise induction with or without concomitant sufentanil in patients ≥ 65 years .
Detailed description
Bispectral index (BIS) is widely used to estimate the depth of anesthesia. In clinical studies, a large variability of BIS has been observed. Several factors may be responsible for this inconsistency. We were able to show that in elderly patients (average age 78 years) receiving increasing doses of propofol alone a BIS values at loss of consciousness (LOC) were about 30% higher compared with young patients (average age 35 years). We showed also that in young patients (average age 48 years) the BIS values at LOC were significantly higher in those receiving sufentanil concomitantly with propofol compared with those who had received propofol alone. It remains unknown, however, whether these data from young surgical patients are applicable to a population of elderly patients. It may be argued that in the elderly receiving propofol, the impact of advance age was so important that any addition of an opioid would not further disturb the sedation-monitor balance. Alternatively, it may be expected that in the elderly receiving an opioid added to propofol the impact of both drugs on sedation will be additive and that previous observations from younger patients will be further exaggerated. The impact of advance age and presence or absence of sufentanil during propofol induction on BIS values at LOC was investigated in this trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sufentanil | Experimental | Drug: SufentanilSufentanil intravenously, continuously with effect-site concentration of 0.3 ng/ml until the end of the study |
| Placebo | Other | Drug: PlaceboSaline intravenously, continuously with the same effect-site concentration as sufentanil (recorded on administration device) until the end of the study |
| Propofol | No intervention | –Open administration using a separate target controlled infusion system and the PK/PD model by Schnider. Initial effect-site concentration 0.5 mcg/ml increased by 0.5 mcg/ml until LOC |
Who may qualify
- Ages
- 70 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age ≥65 years
Key exclusion criteria (5 listed)
- History of heart disease
- History of renal disease
- History of psychiatric
- Obesity
- Allergy to propofol or sufentanil
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 |
|---|---|---|
| SufentanilTo evaluate, in the elderly, the impact of a concomitant administration of sufentanil during a step-wise propofol induction of anaesthesia on the depth of sedation measured using BIS and clinical sedation score. | Drug | Sufentanil |
| PlaceboTo evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness | Drug | Placebo |
Primary outcome
BIS at baseline
Time frame: BIS values at baseline before administration of any study drugs
BIS values in awake patient in supine position, eyes closed, quiet environment
BIS and sufentanil
Time frame: BIS values 10 min after steady state concentration of sufentanil
BIS values recorded after the steady state concentration was obtained and kept during 10min.
BIS and propofol
Time frame: BIS values after steady state concentration of propofol
Propofol was administrated step-wise by increasing concentration of 0.5mcg/ml (0.5, 1.0, 1.5 etc.). After each steady state that was kept during 5 min, BIS values were recorded
BIS and LOC
Time frame: BIS values at loss of consciousness
BIS values were recorded at LOC, that was estimated using a OAA/S scale, a 0-5 point scale, 5 corresponds to a fully awake state, a score of 0 to a completely unresponsive state. A score <2 (absence of response to mild prodding or shaking was regarded as LOC. Blinded to study drug investigator evaluated all sedation scores.
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 Oct 2017.
- Derived from this study: PubMed 29098683de Valence T, Elia N, Czarnetzki C, Dumont L, Tramer MR, Lysakowski C. Effect of sufentanil on bispectral index in the elderly. Anaesthesia. 2018 Feb;73(2):216-222. doi: 10.1111/anae.14102. Epub 2017 Nov 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil in people with Loss of Consciousness, run by University Hospital, Geneva.
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 1 inclusion and 5 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 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
BIS at baseline (time frame: BIS values at baseline before administration of any study drugs). The study lists 4 primary outcomes in all. 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 NCT02831101, which also lists 1 linked publication.
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 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.