Sufentanil Bispectral Index Elderly

October 24, 2017 updated by: Christopher Lysakowski, University Hospital, Geneva

Impact of Sufentanil on the Depth of Sedation Measured by Bispectral Index During Induction of Anaesthesia With Propofol in the Elderly - a Randomised Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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.

Study Type

Study Type

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Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

70 years to 87 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Age ≥65 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Placebo
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
BIS values at baseline before administration of any study drugs
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.
BIS values 10 min after steady state concentration of sufentanil
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
BIS values after steady state concentration of propofol
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.
BIS values at loss of consciousness

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Geneva

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CER 11-25, NAC 11-78

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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