Sufentanil Bispectral Index Elderly

Loss of Consciousness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831101
• Other study ID #: CER 11-25, NAC 11-78
• Status: Completed
• Phase: N/A
• First received: July 1, 2016
• Last updated: October 24, 2017
• Start date: February 2012
• Est. completion date: November 2015

Study information

• Verified date: October 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 87 Years

Eligibility

Inclusion Criteria:

• Age =65 years

Exclusion Criteria:

• History of heart disease

• History of renal disease

• History of psychiatric

• Obesity

• Allergy to propofol or sufentanil

Related Conditions & MeSH terms

• Loss of Consciousness
• Unconsciousness

Intervention

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.
• Placebo
To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS at baseline	BIS values in awake patient in supine position, eyes closed, quiet environment	BIS values at baseline before administration of any study drugs
Primary	BIS and sufentanil	BIS values recorded after the steady state concentration was obtained and kept during 10min.	BIS values 10 min after steady state concentration of sufentanil
Primary	BIS and 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 values after steady state concentration of propofol
Primary	BIS and LOC	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.	BIS values at loss of consciousness