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Sufentanil Bispectral Index Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02831101
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
Christopher Lysakowski, University Hospital, Geneva

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

Condition or disease Intervention/treatment Phase
Loss of Consciousness Drug: Sufentanil Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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 Start Date : February 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sufentanil
Sufentanil intravenously, continuously with effect-site concentration of 0.3 ng/ml until the end of the study
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.

Saline intravenously, continuously with the same effect-site concentration as sufentanil (recorded on administration device) until the end of the study
Drug: Placebo
To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness

No Intervention: Propofol
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

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 87 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Age ≥65 years

Exclusion Criteria:

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Christopher Lysakowski, MD PD, University Hospital, Geneva Identifier: NCT02831101    
Other Study ID Numbers: CER 11-25, NAC 11-78
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Christopher Lysakowski, University Hospital, Geneva:
Loss of consciousness
Additional relevant MeSH terms:
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Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia