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Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00162591
Enrollment
40
Registered
2005-09-13
Start date
2004-10-31
Completion date
Unknown
Last updated
2005-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Bispectral index, sedation, remifentanyl, Bronchoalveolar lavage, Intensive care, Nociceptive stimuli, Sedated patient, BIS variation

Brief summary

The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

Detailed description

Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage. The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage. It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients. The hypothesis is that BIS can study analgesia in sedated patient.

Interventions

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion criteria

* Pace maker * Neurologic illness * Hemodynamic instability * Hypothermia

Design outcomes

Primary

MeasureTime frame
BIS variation during bronchoalveolar lavage

Secondary

MeasureTime frame
Systolic blood pressure, diastolic blood pressure, heart rate viation

Countries

France

Contacts

Primary ContactQUINTARD h Hervé, MD
quintard@libertysurf.fr+33140258816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026