Sufentanil Bispectral Index Elderly
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|ClinicalTrials.gov Identifier: NCT02831101|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 25, 2017
University Hospital, Geneva
Information provided by (Responsible Party):
Christopher Lysakowski, University Hospital, Geneva
We compared BIS values during propofol stepwise induction with or without concomitant sufentanil in patients ≥ 65 years .
|Condition or disease||Intervention/treatment||Phase|
|Loss of Consciousness||Drug: Sufentanil Drug: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Sufentanil intravenously, continuously with effect-site concentration of 0.3 ng/ml until the end of the study
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.
Saline intravenously, continuously with the same effect-site concentration as sufentanil (recorded on administration device) until the end of the study
To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness
No Intervention: Propofol
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
Primary Outcome Measures :
- 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.
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