We compared BIS values during propofol stepwise induction with or without concomitant sufentanil in patients ≥ 65 years .
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: November 2015
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.
- Drug: Sufentanil
- 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.
- Drug: Placebo
- To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness
Arms, Groups and Cohorts
- Experimental: Sufentanil
- Sufentanil intravenously, continuously with effect-site concentration of 0.3 ng/ml until the end of the study
- Other: Placebo
- Saline intravenously, continuously with the same effect-site concentration as sufentanil (recorded on administration device) until the end of the study
- 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
Clinical Trial 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.
Participating in This Clinical Trial
- Age ≥65 years Exclusion Criteria:
- History of heart disease – History of renal disease – History of psychiatric – Obesity – Allergy to propofol or sufentanil
Gender Eligibility: All
Minimum Age: 70 Years
Maximum Age: 87 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University Hospital, Geneva
- Provider of Information About this Clinical Study
- Principal Investigator: Christopher Lysakowski, MD PD – University Hospital, Geneva
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