Sufentanil Bispectral Index Elderly

University Hospitals (UH)

Status: Completed

Conditions: Loss of Consciousness

Treatments: Drug: Sufentanil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02831101

CER 11-25, NAC 11-78

Details and patient eligibility

About

We compared BIS values during propofol stepwise induction with or without concomitant sufentanil in patients ≥ 65 years .

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 70 to 87 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥65 years

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

71 participants in 3 patient groups

Sufentanil

Experimental group

Description:

Sufentanil intravenously, continuously with effect-site concentration of 0.3 ng/ml until the end of the study

Treatment:

Drug: Sufentanil

Placebo

Other group

Description:

Saline intravenously, continuously with the same effect-site concentration as sufentanil (recorded on administration device) until the end of the study

Treatment:

Drug: Placebo

Propofol

No Intervention group

Description:

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