Sufentanil Bispectral Index Elderly

Not Applicable

Completed

• Conditions: Loss of Consciousness
• Interventions: Drug: Sufentanil; Drug: Placebo

• Registration Number: NCT02831101
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Age ≥65 years

Exclusion Criteria

• History of heart disease
• History of renal disease
• History of psychiatric
• Obesity
• Allergy to propofol or sufentanil

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sufentanil	Sufentanil	Sufentanil intravenously, continuously with effect-site concentration of 0.3 ng/ml until the end of the study
Placebo	Placebo	Saline intravenously, continuously with the same effect-site concentration as sufentanil (recorded on administration device) until the end of the study

Primary Outcome Measures

Name	Time	Method
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 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 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.