Sufentanil Bispectral Index Elderly
Primary Purpose
Loss of Consciousness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sufentanil
Placebo
Sponsored by
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
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
NCT ID
NCT02831101
First Posted
July 1, 2016
Last Updated
October 24, 2017
Sponsor
University Hospital, Geneva
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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