Completed

NCT Number: NCT01171833

Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics

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).

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Key information

Conditions

Pharmacokinetics of Inhaled Anesthetics Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

2.0 vol% prefilled in a corrugated circuit.

Other names: Sevorane

Desflurane

Drug

6.0 vol% prefilled in a corrugated circuit.

Other names: Suprane

Isoflurane

Drug

1.2 vol% prefilled in a corrugated circuit.

Other names: Aerane

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Registry information

Official study title

Effect of Ventilation on Speed of Induction of Anesthesia in Desflurane, Sevoflurane, and Isoflurane

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jul 29, 2010
Registry last updated: Aug 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed