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Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT00665119
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Fondazione Poliambulanza Istituto Ospedaliero

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Respiration, Artificial Conscious Sedation Drug: remifentanil Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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.
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 %




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: April 23, 2008    Key Record Dates
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