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Sufentanil Bispectral Index Elderly

Primary Purpose

Loss of Consciousness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sufentanil
Placebo
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Loss of Consciousness focused on measuring BIS, Elderly, Propofol, Sufentanil, Loss of consciousness

Eligibility Criteria

70 Years - 87 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Other

    No Intervention

    Arm Label

    Sufentanil

    Placebo

    Propofol

    Arm Description

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

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

    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

    Outcomes

    Primary Outcome Measures

    BIS at baseline
    BIS values in awake patient in supine position, eyes closed, quiet environment
    BIS and sufentanil
    BIS values recorded after the steady state concentration was obtained and kept during 10min.
    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 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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 1, 2016
    Last Updated
    October 24, 2017
    Sponsor
    University Hospital, Geneva
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02831101
    Brief Title
    Sufentanil Bispectral Index Elderly
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Geneva

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Loss of Consciousness
    Keywords
    BIS, Elderly, Propofol, Sufentanil, Loss of consciousness

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sufentanil
    Arm Type
    Experimental
    Arm Description
    Sufentanil intravenously, continuously with effect-site concentration of 0.3 ng/ml until the end of the study
    Arm Title
    Placebo
    Arm Type
    Other
    Arm Description
    Saline intravenously, continuously with the same effect-site concentration as sufentanil (recorded on administration device) until the end of the study
    Arm Title
    Propofol
    Arm Type
    No Intervention
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Sufentanil
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness
    Primary Outcome Measure Information:
    Title
    BIS at baseline
    Description
    BIS values in awake patient in supine position, eyes closed, quiet environment
    Time Frame
    BIS values at baseline before administration of any study drugs
    Title
    BIS and sufentanil
    Description
    BIS values recorded after the steady state concentration was obtained and kept during 10min.
    Time Frame
    BIS values 10 min after steady state concentration of sufentanil
    Title
    BIS and propofol
    Description
    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
    Time Frame
    BIS values after steady state concentration of propofol
    Title
    BIS and LOC
    Description
    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.
    Time Frame
    BIS values at loss of consciousness

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Maximum Age & Unit of Time
    87 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Age ≥65 years Exclusion Criteria: History of heart disease History of renal disease History of psychiatric Obesity Allergy to propofol or sufentanil

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29098683
    Citation
    de Valence T, Elia N, Czarnetzki C, Dumont L, Tramer MR, Lysakowski C. Effect of sufentanil on bispectral index in the elderly. Anaesthesia. 2018 Feb;73(2):216-222. doi: 10.1111/anae.14102. Epub 2017 Nov 3.
    Results Reference
    derived

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    Sufentanil Bispectral Index Elderly

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