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Completed

NCT Number: NCT02831101

Sufentanil Bispectral Index Elderly

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

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Key information

Conditions

Loss of Consciousness Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

70 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥65 years

Exclusion criteria

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

Treatment and study plan

Sufentanil

Drug

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

Drug

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2016
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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