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Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00665119
First Posted: April 23, 2008
Last Update Posted: December 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fondazione Poliambulanza Istituto Ospedaliero
  Purpose
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.

Condition Intervention Phase
Respiratory Insufficiency Respiration, Artificial Conscious Sedation Drug: remifentanil Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.

Resource links provided by NLM:


Further study details as provided by Fondazione Poliambulanza Istituto Ospedaliero:

Primary Outcome Measures:
  • respiratory rate/tidal volume [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
  • pressure-time product [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]

Secondary Outcome Measures:
  • double product of respiratory system [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
  • dynamic intrinsic PEEP [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
  • adverse events [ Time Frame: during all the study period ]
  • arterial pH [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
  • level of sedation (RASS) [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]

Enrollment: 14
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: remifentanil
0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion
Drug: placebo
NaCl 0.9 %

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665119


Locations
Italy
Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Sponsors and Collaborators
Fondazione Poliambulanza Istituto Ospedaliero
Investigators
Principal Investigator: Giuseppe Natalini, MD Fondazione Poliambulanza Istituto Ospedaliero
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Natalini Giuseppe, FPoliambulanza
ClinicalTrials.gov Identifier: NCT00665119     History of Changes
Other Study ID Numbers: FP-TIP-01
First Submitted: April 18, 2008
First Posted: April 23, 2008
Last Update Posted: December 18, 2008
Last Verified: December 2008

Keywords provided by Fondazione Poliambulanza Istituto Ospedaliero:
Respiratory Insufficiency
Respiration, Artificial
Remifentanil
Respiratory Mechanics
Work of Breathing

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics