Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Pharmacokinetics of Inhaled Anesthetics |
Drug: Sevoflurane Drug: Desflurane Drug: Isoflurane |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Effect of Ventilation on Speed of Induction of Anesthesia in Desflurane, Sevoflurane, and Isoflurane |
- 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 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 36 |
| Study Start Date: | June 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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) |
Drug: Sevoflurane
2.0 vol% prefilled in a corrugated circuit.
Other Name: Sevorane
|
|
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) |
Drug: Desflurane
6.0 vol% prefilled in a corrugated circuit.
Other Name: Suprane
|
|
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) |
Drug: Isoflurane
1.2 vol% prefilled in a corrugated circuit.
Other Name: Aerane
|
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).
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Junyong In, Assistant professor, DongGuk University |
| ClinicalTrials.gov Identifier: | NCT01171833 History of Changes |
| Other Study ID Numbers: | J In 2010-1 |
| Study First Received: | July 28, 2010 |
| Last Updated: | August 9, 2012 |
| Health Authority: | Korea: Food and Drug Administration Korea: Institutional Review Board |
Keywords provided by DongGuk University:
|
Anesthetic induction Desflurane Isoflurane Sevoflurane Ventilation |
Additional relevant MeSH terms:
|
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Anesthetics Isoflurane Desflurane Sevoflurane |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on October 17, 2012
