Pharmacokinetics of Inhaled AnestheticsNCT01171833
Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics
A study testing Sevoflurane, Desflurane and Isoflurane in people with Pharmacokinetics of Inhaled Anesthetics, run by DongGuk University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pharmacokinetics of Inhaled Anesthetics
- What is being tested?
- Sevoflurane, Desflurane and Isoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA PS I, II
- Age: 20-60 years male and female
- Elective schedule with minor surgery
- BMI < 30
Who cannot join
- 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
About this study
Official title: 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).
Read the 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).
- Conditions
- Pharmacokinetics of Inhaled Anesthetics
- Being tested
- Sevoflurane, Desflurane, Isoflurane
- Keywords
- Anesthetic induction, Desflurane, Isoflurane, Sevoflurane, Ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
2.0 vol% prefilled in a corrugated circuit.
DesfluraneDrug
Also called Suprane
6.0 vol% prefilled in a corrugated circuit.
IsofluraneDrug
Also called Aerane
1.2 vol% prefilled in a corrugated circuit.
| Study group | Role | What they receive |
|---|---|---|
| Group A(Sevoflurane) | Experimental | 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) Receives: Drug: Sevoflurane |
| Group B(Desflurane) | Experimental | 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) Receives: Drug: Desflurane |
| Group C(Isoflurane) | Experimental | 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) Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal concentrations of isoflurane, sevoflurane and desflurane, and BIS values with hypo-, normo-, hyperventilation
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.
Measured: at 0, 30, 60, 90, 120, 180, 240, 300, 360, 480, 600, 720 sec after volatile gas starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of Inhaled AnestheticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyong In, DongGuk University
- Investigators
- Junyong In, MD, Principal investigator, Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171833
- Sponsor's protocol ID
- J In 2010-1
- Status last verified
- Aug 2012
- First submitted
- 28 Jul 2010
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ventilation on Speed of Induction of Anesthesia in Desflurane, Sevoflurane, and Isoflurane
- ClinicalTrials.gov ID
- NCT01171833
- Acronym / sponsor ID
- J In 2010-1
- Conditions
- Pharmacokinetics of Inhaled Anesthetics
- Keywords
- Anesthetic induction, Desflurane, Isoflurane, Sevoflurane, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A(Sevoflurane) | Experimental | Drug: SevofluraneTwelve 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) |
| Group B(Desflurane) | Experimental | Drug: DesfluraneTwelve 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) |
| Group C(Isoflurane) | Experimental | Drug: IsofluraneTwelve 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) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA PS I, II
- Age: 20-60 years male and female
- Elective schedule with minor surgery
- BMI < 30
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: Sevorane2.0 vol% prefilled in a corrugated circuit. | Drug | Group A(Sevoflurane) |
| DesfluraneAlso: Suprane6.0 vol% prefilled in a corrugated circuit. | Drug | Group B(Desflurane) |
| IsofluraneAlso: Aerane1.2 vol% prefilled in a corrugated circuit. | Drug | Group C(Isoflurane) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junyong In, MD principal investigator
Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane, Desflurane and Isoflurane in people with Pharmacokinetics of Inhaled Anesthetics, run by DongGuk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2012.