Loss of Consciousness
Conditions
Keywords
BIS, Elderly, Propofol, Sufentanil, Loss of consciousness
Brief summary
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.
Interventions
DRUGSufentanil
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.
DRUGPlacebo
To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
70 Years to 87 Years
Healthy volunteers
No
Inclusion criteria
\- Age ≥65 years
Exclusion criteria
* History of heart disease * History of renal disease * History of psychiatric * Obesity * Allergy to propofol or sufentanil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BIS at baseline | 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 | 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 | 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 | 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. |
Outcome results
None listed