Sufentanil Bispectral Index Elderly

NCT02831101 | Completed

• 1 other identifier: CER 11-25, NAC 11-78
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Loss of Consciousness

Keywords

BIS; Elderly; Propofol; Sufentanil; Loss of consciousness

Outcome Measures

Primary Outcomes (4)

• BIS at baseline

  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

  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

  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

  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

Study Arms (3)

Sufentanil

EXPERIMENTAL

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

Drug: Sufentanil

Placebo

OTHER

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

Drug: Placebo

Propofol

NO INTERVENTION

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

Interventions

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.

Sufentanil

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

Placebo

Eligibility Criteria

• Age: 70 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- Age ≥65 years

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Related Publications (1)

• 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.

  PMID: 29098683 DERIVED

MeSH Terms

Conditions

Unconsciousness

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PD

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 13, 2016
• Study Start: February 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share