- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171833
Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics
Effect of Ventilation on Speed of Induction of Anesthesia in Desflurane, Sevoflurane, and Isoflurane
Three groups of patients are going to have minor surgery under general anesthesia with inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg, respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be observed differences among the groups for ventilatory effects on speed of induction.
Duration of this randomised controlled trial will be about 3 months. Estimated sample size will be 36 patients(12 in each group).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
No premedicant will be given. The anesthetic workstation and a circulatory circuit will be prefilled with 1.0 MAC of inhaled anesthetic that will be selected randomly.
- Group A (n=12): Sevoflurane 2.0 vol%
- Group B (n=12): Desflurane 6.0 vol%
- Group C (n=12): Isoflurane 1.2 vol%
Each group has 3 subgroups according to the ventilatory setting that will also be randomly determined.
- Hypoventilation: tidal volume 8 ml/kg, respiratory rate 10 /min
- Normoventilation: tidal volume 10 ml/kg, respiratory rate 10 /min
- Hyperventilation: tidal volume 12 ml/kg, respiratory rate 10 /min
Patients will be preoxygenated with 100% oxygen (5 L/min) for 5 minutes under pulse oximeter, EKG, and noninvasive blood pressure monitoring. Bispectral index (BIS) monitor will be applied.
The induction of general anesthesia will start with propofol (2 mg/kg), rocuronium (0.8 mg/kg) and remifentanil infusion (0.1 mcg/kg/min). The size of a tracheal tube will be 7.5 mm (ID) for male, 7.0 mm (ID) for female. After intubation, anesthesia workstation will be connected to the tracheal tube. Ventilation will start, and that point will be time 0. During 720 seconds, inspiratory (PIgas) and end-tidal concentration of inhaled anesthetics (ETgas), end-tidal partial pressure of carbon dioxide, and BIS will be measured at time 0, 30, 60, 90, 120 ,150, 180, 240, 300, 360, 480, 600, and 720 seconds. Mean blood pressure and heart rate will also be recorded every 2 minutes. Fresh gas flow will be kept at 6 L/min with 100% oxygen.
The fraction of ETgas/PIgas will be analyzed with nonlinear mixed effects modeling.
Estimated sample size will be 36 patients (12 in each group, 4 in each ventilatory settings).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA PS I, II
- Age: 20-60 years male and female
- Elective schedule with minor surgery
- BMI < 30
Exclusion Criteria:
- Patients with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history
- Upper airway anomaly or deformity
- ASA PS III or higher
- Pregnant women
- BMI >= 30
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A(Sevoflurane)
Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min) |
2.0 vol% prefilled in a corrugated circuit.
Other Names:
|
Experimental: Group B(Desflurane)
Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min) |
6.0 vol% prefilled in a corrugated circuit.
Other Names:
|
Experimental: Group C(Isoflurane)
Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min) |
1.2 vol% prefilled in a corrugated circuit.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
End-tidal concentrations of isoflurane, sevoflurane and desflurane, and BIS values with hypo-, normo-, hyperventilation
Time Frame: at 0, 30, 60, 90, 120, 180, 240, 300, 360, 480, 600, 720 sec after volatile gas starts
|
The inspiratory, and end-tidal concentrations of volatile anesthetics, partial pressure of end-tidal carbon dioxide will be recorded from an S/5 Avance anesthetic workstation (Datex-Ohmeda) and an embedded monitor.
BIS values are measured with a BIS monitor.
|
at 0, 30, 60, 90, 120, 180, 240, 300, 360, 480, 600, 720 sec after volatile gas starts
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Junyong In, MD, Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- J In 2010-1
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