Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

NCT00665119 | Completed Phase 4

• 1 other identifier: FP-TIP-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Insufficiency; Respiration, Artificial; Conscious Sedation

Keywords

Respiratory Insufficiency; Respiration, Artificial; Remifentanil; Respiratory Mechanics; Work of Breathing

Outcome Measures

Primary Outcomes (2)

• respiratory rate/tidal volume

  before and after remifentanil infusion; before and after placebo infusion.

• pressure-time product

  before and after remifentanil infusion; before and after placebo infusion.

Secondary Outcomes (5)

• double product of respiratory system

  before and after remifentanil infusion; before and after placebo infusion.

• dynamic intrinsic PEEP

  before and after remifentanil infusion; before and after placebo infusion.

• adverse events

  during all the study period

• arterial pH

  before and after remifentanil infusion; before and after placebo infusion.

• level of sedation (RASS)

  before and after remifentanil infusion; before and after placebo infusion.

Study Arms (1)

treatment

EXPERIMENTAL

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.

Drug: remifentanil; Drug: placebo

Interventions

remifentanil DRUG

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

treatment

placebo DRUG

NaCl 0.9 %

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero: lead

Study Sites (1)

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

Related Publications (1)

• 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.

  PMID: 21333087 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Giuseppe Natalini, MD

  Fondazione Poliambulanza Istituto Ospedaliero

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

IT (1)