Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy
NCT ID: NCT01470170
Last Updated: 2015-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
173 participants
INTERVENTIONAL
2010-10-31
2011-12-31
Brief Summary
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Detailed Description
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Method: patients will be enrolled and assigned randomly into five groups. In group 1, normal saline two minutes before and Alf 2.5μg/kg before Pro were given; In group 2, normal saline two minutes before and Alf 5μg/kg before Pro were given; In group 3, Alf 2.5μg/kg two minutes before and normal saline before Pro were given; In group 4: Alf 5μg/kg two minutes before and normal saline before Pro were given; in group 5, normal saline two minutes and before Pro were given.
Concentration of effect site to loss of consciousness (LOC), dose of Pro to LOC, and induction time of variable regimen, as well as hypoxemia, hypotension, cough severity, and Pro injection related pain will be recorded and analyzed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group1
Alfentanil 2.5μg/kg before propofol
Alfentanil
Give Alfentanil before TCI Propofol sedative bronchoscope
Normal saline
Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.
Targeted controlled infusion
The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model
Propofol
The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
Group2
Alfentanil 5μg/kg before propofol
Alfentanil
Give Alfentanil before TCI Propofol sedative bronchoscope
Normal saline
Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.
Targeted controlled infusion
The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model
Propofol
The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
Group 3
Alfentanil 2.5μg/kg two minutes before propofol
Alfentanil
Give Alfentanil before TCI Propofol sedative bronchoscope
Normal saline
Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.
Targeted controlled infusion
The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model
Propofol
The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
Group 4
Alfentanil 5μg/kg two minutes before propofol
Alfentanil
Give Alfentanil before TCI Propofol sedative bronchoscope
Normal saline
Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.
Targeted controlled infusion
The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model
Propofol
The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
Group 5 Control
propofol alone
Normal saline
Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.
Targeted controlled infusion
The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model
Propofol
The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
Interventions
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Alfentanil
Give Alfentanil before TCI Propofol sedative bronchoscope
Normal saline
Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.
Targeted controlled infusion
The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model
Propofol
The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* hypersensitivity or allergy to Propofol, Alfentanil
* severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, or requirement for oxygen therapy)
* unstable haemodynamic status (defined as a heart rate \< 60 or ≧ 120 bpm and/or
* a systolic blood pressure (SBP) \< 100 or ≧ 180 mmHg)
* predictable difficult upper airways (Mallampati classification score of IV)
* severe obstructive sleep apnea with apnea hypopnea index (AHI) \> 45
* Body mass index (BMI) more than 42 in male and 35 in female
* renal insufficiency
* liver cirrhosis
18 Years
80 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Chung-Hsing, Hsieh
Chief of Medical Intensive Care Unit, Department of Internal Medicine, Chang-Gung Memorial Hospital, Taipei
Principal Investigators
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Chung Hsing Hsieh, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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99-1538A3
Identifier Type: -
Identifier Source: org_study_id
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