MedDataX Logo

Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

NCT ID: NCT00665119

Last Updated: 2008-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high respiratory rate.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Insufficiency Respiration, Artificial Conscious Sedation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Respiratory Insufficiency Respiration, Artificial Remifentanil Respiratory Mechanics Work of Breathing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

treatment

Any patient alternatively receive both remifentanil and isotonic saline (placebo)infusion. The order of infusion is randomized. An interval of 30 minutes is planned between the two infusions.

Group Type EXPERIMENTAL

remifentanil

Intervention Type DRUG

0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion

placebo

Intervention Type DRUG

NaCl 0.9 %

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

remifentanil

0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion

Intervention Type DRUG

placebo

NaCl 0.9 %

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* pressure support ventilation or CPAP
* respiratory rate \> 35.min-1
* respiratory rate/tidal volume \> 105

Exclusion Criteria

* vasoactive agents (dopamine lower than 5 mcg.kg-1.min-1 is not considered as vasoactive agent)
* body temperature \> 38 °C
* Glasgow Coma Scale \< 9
* FIO2 \> 0.6
* PEEP \> 10 cmH2O
* pH \< 7.30
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione Poliambulanza Istituto Ospedaliero

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

FPoliambulanza

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giuseppe Natalini, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Poliambulanza Istituto Ospedaliero

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Natalini G, Di Maio A, Rosano A, Ferretti P, Bertelli M, Bernardini A. Remifentanil improves breathing pattern and reduces inspiratory workload in tachypneic patients. Respir Care. 2011 Jun;56(6):827-33. doi: 10.4187/respcare.01014. Epub 2011 Feb 11.

Reference Type DERIVED
PMID: 21333087 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FP-TIP-01

Identifier Type: -

Identifier Source: org_study_id