Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients - Full Text View

Sponsored by:	Fondazione Poliambulanza Istituto Ospedaliero
Information provided by:	Fondazione Poliambulanza Istituto Ospedaliero
ClinicalTrials.gov Identifier:	NCT00665119

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 IV

Drug Information available for: Remifentanil Remifentanil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.

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

Responsible Party:	FPoliambulanza ( Natalini Giuseppe )
Study ID Numbers:	FP-TIP-01
Study First Received:	April 18, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00665119
Health Authority:	Italy: Ethics Committee

Keywords provided by Fondazione Poliambulanza Istituto Ospedaliero:

Respiratory Insufficiency
Respiration, Artificial
Remifentanil
Respiratory Mechanics
Work of Breathing

Study placed in the following topic categories:

Respiratory Insufficiency
Remifentanil
Respiratory Tract Diseases
Respiration Disorders

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Pharmacologic Actions
Sensory System Agents
Anesthetics, General

Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009