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Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
Information provided by:
Fondazione Poliambulanza Istituto Ospedaliero
ClinicalTrials.gov Identifier:
NCT00665119
First received: April 18, 2008
Last updated: December 17, 2008
Last verified: December 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]
  • pressure-time product [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • double product of respiratory system [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ] [ Designated as safety issue: No ]
  • dynamic intrinsic PEEP [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: during all the study period ] [ Designated as safety issue: Yes ]
  • arterial pH [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ] [ Designated as safety issue: Yes ]
  • level of sedation (RASS) [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ] [ Designated as safety issue: Yes ]

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
Other Name: Remifentanil
Drug: placebo
NaCl 0.9 %

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Fondazione Poliambulanza Istituto Ospedaliero

Additional 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
Study First Received: April 18, 2008
Last Updated: December 17, 2008
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013